Process / Project Engineer – nPVC Systems & Advanced Manufacturing Location: Castlebar, Ireland Contract: 12‑month contract (potential extension) Role Overview Opportunity for an experienced engineer to support the industrialisation and scale‑up of non‑PVC (nPVC) medical device systems. This role focuses on polymer‑based manufacturing, container‑closure systems, capital equipment, and validation within a regulated environment. Key Responsibilities Technical & Process Development <ul><li>Lead design transfer and industrialisation of nPVC bags, ports, connectors, and assemblies.</li><li>Support conversion from PVC to nPVC materials and multilayer film technologies.</li><li>Provide expertise in sealing, forming, and container‑closure integrity.</li></ul>Capital Equipment & Automation <ul><li>Define URS for new/modified equipment (bag porting, connector welding, automated assembly).</li><li>Support vendor engagement, FAT/SAT, installation, and commissioning.</li><li>Ensure equipment scalability and alignment with automation needs.</li></ul>Validation & Compliance <ul><li>Lead IQ/OQ/PQ for new and modified processes.</li><li>Support sterilisation validation and equivalency strategies.</li><li>Prepare and approve GMP‑compliant documentation (protocols, reports, risk assessments).</li></ul>Regulatory Support <ul><li>Contribute to regulatory‑critical changes (supplier qualification, material changes, E&L, biocompatibility).</li><li>Ensure technical justifications are audit‑ready.</li></ul>Cross‑Functional Collaboration <ul><li>Work with Manufacturing, Quality, R&D, Procurement, Regulatory, and suppliers.</li><li>Support alignment across global sites and lead structured problem‑solving.</li></ul>Requirements Essential <ul><li>Level 8 degree in Mechanical, Polymer, Biomedical, Manufacturing Engineering, or similar.</li><li>5 years in Medical Device, Pharma, or regulated manufacturing.</li><li>Strong polymer manufacturing experience (films, extrusion, moulding, packaging).</li><li>Proven capital project delivery and process validation (IQ/OQ/PQ).</li><li>Knowledge of SPC, DOE, OEE, and process optimisation.</li></ul>Desirable <ul><li>Experience with nPVC systems, multilayer films, or polyolefin elastomers.</li><li>Experience with sterile bag‑based products or dialysis systems.</li><li>Knowledge of sealing technologies, container‑closure integrity, and sterile packaging.</li><li>Exposure to E&L, biocompatibility, and regulatory‑impacting changes.</li></ul>Skills & Attributes <ul><li>Strong technical judgement and hands‑on problem‑solving.</li><li>Effective communicator with cross‑functional teams.</li><li>Self‑driven, organised, and comfortable in fast‑moving environments.</li><li>Excellent documentation discipline.</li></ul>

Project Process Engineer - Contract

Overview An exciting opportunity has arisen for a Building/Office Receptionist  to join a property management team responsible for the day-to-day operation of a modern commercial office development and wider mixed-use estate. The role combines front-of-house reception duties with property management and administrative support. It would suit an organised, proactive individual with at least one year’s experience in administration, facilities, or commercial property management. Key Responsibilities:  Front of House & Administration <ul><li>Act as the first point of contact for visitors, clients, and staff</li><li>Professionally welcome guests, provide information, and direct them appropriately</li><li>Manage reception operations and maintain a professional front-of-house environment</li><li>Schedule appointments, coordinate meetings, and manage meeting room bookings</li><li>Handle general administrative tasks including filing, data entry, and ordering supplies</li><li>Manage incoming and outgoing post and deliveries</li></ul> Property & Facilities Support <ul><li>Support the Property Manager in the day-to-day management of the building within agreed budgets</li><li>Coordinate planned and reactive maintenance works through a purchase order system</li><li>Assist in preparing annual budgets and reviewing expenditure on a quarterly basis</li><li>Conduct regular site inspections and maintain accurate records and reports</li><li>Liaise with tenants regarding general building operations and queries</li><li>Assist in the implementation and management of ESG (Environmental, Social & Governance) initiatives</li><li>Input and maintain property data on ESG and facilities management platforms</li></ul> Operations & Security <ul><li>Assist in maintaining building security and ensuring access control procedures are followed</li><li>Coordinate with cleaning and maintenance contractors to ensure service standards are met</li><li>Manage access systems, car park facilities, and shared/common areas</li><li>Ensure contractors and visitors are appropriately authorised and inducted where required</li></ul> Person Specification <ul><li>Strong communication and interpersonal skills</li><li>Professional, approachable, and customer-focused manner</li><li>Minimum 1 year experience in administration, facilities, or commercial property environment</li><li>Property or Facilities Management qualification (desirable but not essential)</li><li>Good technical understanding or interest in building/facilities operations</li><li>Excellent IT, organisational, and administrative skills</li><li>Proactive, reliable, and able to use initiative</li><li>Strong ability to prioritise tasks and meet deadlines</li><li>Comfortable managing multiple ongoing responsibilities in a busy environment</li></ul> For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Building Receptionist

Director of Operations Quality Location: Galway (On‑site, Full Time) Role Overview The Director of Operations Quality is responsible for leading and overseeing all quality activities related to manufacturing and supply chain operations. This role provides strategic and hands‑on quality leadership, ensuring that production processes, materials, and products meet all applicable regulatory and quality system requirements. The position requires strong operational oversight, team leadership, and the ability to drive continuous improvement within a fast‑paced, growth‑oriented environment. Key Responsibilities Operational Quality Leadership <ul><li>Lead quality activities at manufacturing sites, including incoming inspection, in‑process controls, final release, and batch record review and disposition.</li><li>Maintain governance over product release and batch record control.</li><li>Implement and enforce in‑process controls and statistical process control (SPC) to improve yield and reduce variability.</li></ul>Team Management <ul><li>Manage, mentor, and develop the on‑site operations quality team.</li><li>Recruit, train, and build a high‑performing quality organization.</li><li>Promote a strong culture of quality across manufacturing operations.</li></ul>Quality Systems & Compliance <ul><li>Approve and control production quality procedures, work instructions, and QC sampling plans.</li><li>Manage deviations, nonconformances, CAPAs, and root cause investigations; ensure timely closure and effectiveness checks.</li><li>Ensure compliance with ISO 13485, MDR/MDD, 21 CFR Part 820, and other applicable regulations.</li><li>Support internal and external audits related to manufacturing; lead responses to operations‑related findings.</li></ul>Validation & Process Control <ul><li>Oversee production‑related validations and qualifications, including process validation, equipment qualification, and environmental controls.</li><li>Ensure validation documentation is audit‑ready and compliant with regulatory expectations.</li><li>Support process changes, scale‑up activities, capacity increases, and the transfer of new products or processes into production.</li></ul>Supplier Quality <ul><li>Drive supplier quality management for production materials, including supplier selection, audits, performance monitoring, and corrective actions.</li><li>Manage incoming quality agreements and ensure supplier‑related issues are addressed effectively.</li></ul>Facility & Environmental Controls <ul><li>Oversee routine sterilization controls and lot release processes.</li><li>Ensure cleanroom control measures are implemented and maintained.</li><li>Lead quality aspects of facility expansion initiatives, ensuring quality requirements are integrated into new manufacturing layouts and workflows.</li></ul>Performance Monitoring <ul><li>Develop and report KPIs related to product quality, scrap/rework, deviations, and CAPA effectiveness.</li><li>Provide regular updates to senior leadership on operational quality performance.</li></ul>Professional Qualifications & Attributes <ul><li>Degree in life sciences, engineering, or a related discipline; advanced degree preferred.</li><li>8 years of experience in medical device quality, with significant hands‑on manufacturing and supplier quality experience.</li><li>Proven leadership experience managing quality teams.</li><li>Strong knowledge of ISO 13485 and relevant regulatory requirements (MDR, 21 CFR Part 820).</li><li>Demonstrated experience with production transfers, process validation, and manufacturing CAPA management.</li><li>Proficient in SPC, FMEA, and root cause analysis tools (8D, Fishbone, 5 Whys).</li></ul>

Director of Operations - Quality

Job Title:    CNC Operator Location:    Galway Status:     Permanent Position Summary:   <ul><li>We are seeking skilled CNC Operators to join a growing engineering team working on advanced industrial machinery platforms.</li><li>As the CNC Operator the role typically involves running precision machining equipment in a manufacturing environment</li></ul>  Key Responsibilities: <ul><li>Set up and operate CNC lathes or milling machines to produce precision parts</li><li>Load raw materials, change tooling, and adjust machine offsets</li><li>Read engineering drawings and specifications</li><li>Troubleshoot minor machine issues and optimise cycle times</li><li>Work with materials like steel, aluminium & stainless steel</li></ul> Qualifications and Requirements: <ul><li>Ability to read blueprints</li><li>Basic machining or CNC experience</li><li>Familiarity with measuring tools and tolerance</li><li>CAM software knowledge ideally</li></ul>  For a confidential conversation about the position contact Karl on 353 86 201 1223 or klippett@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

CNC Operator

Job Title:     Software Engineer   Location:     Galway Status:      Permanent Position Summary:   <ul><li>We are seeking a skilled Software Engineer – Machine Controls & Connectivity to join a growing engineering team working on advanced industrial machinery platforms.</li><li>This role focuses on the development, optimization, and localization of next-generation machine control systems, combining PLC programming, motion control, and modern connectivity solutions.</li><li>You will play a key role in evolving control platforms while collaborating with international engineering teams.</li></ul>  Key Responsibilities: <ul><li>Develop and optimize PLC software using CODESYS or similar platforms</li><li>Implement and refine motion control systems, including servo integration</li><li>Develop and enhance HMI applications using C# or similar technologies</li><li>Improve usability and workflow for machine operators</li><li>Support integration with external systems (e.g., MES, APIs)</li><li>Work with industrial communication protocols (e.g., OPC UA</li><li>Act as a technical interface between global engineering teams</li></ul> Qualifications and Requirements: Education & Experience: <ul><li>Degree in Electrical Engineering, Automation, Computer Science, Mechatronics, or related field</li><li>Proven experience in industrial automation or machinery environments</li></ul>  Technical Skills: <ul><li>Strong PLC programming experience (CODESYS preferred)</li><li>Solid understanding of motion control, servo systems, and industrial automation</li><li>Experience with C# development for HMI or application software</li><li>Familiarity with version control and structured software development processes</li></ul>  Desirable Skills: <ul><li>Experience with MES integration, REST APIs, or OPC UA</li><li>Exposure to cloud platforms (e.g., AWS)</li><li>Knowledge of machine safety standards and compliance</li></ul>  For a confidential conversation about the position contact Karl on 353 86 201 1223 or klippett@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Software Engineer

Job Title:     Mechatronics Engineer   Location:    Galway Status:     Permanent Position Summary: <ul><li>We are seeking a skilled Mechatronics Engineer to design and deliver robot-integrated automation solutions across Europe, with a focus on integrating UR and FANUC robots into industrial machine environments.</li><li>This role is centered on building robust, standardised, and scalable automation systems while ensuring safety, performance, and alignment with European requirements.</li></ul>Key Responsibilities: <ul><li>Develop and support UR and FANUC robot integration with industrial machinery</li><li>Design robot-to-machine interfaces including I/O, safety signals, and sequencing</li><li>Implement industrial communication protocols</li><li>Ensure compliance with CE marking and EU machine safety standards</li><li>Support installation, commissioning, and troubleshooting at customer sites</li><li>Collaborate with global engineering teams to align integration strategies</li></ul> Qualifications and Requirements: <ul><li>Degree in Mechatronics, Robotics, Electrical Engineering, Automation, or related field</li><li>Proven experience integrating industrial or collaborative robots (UR and/or FANUC)</li><li>Strong hands-on experience with robot-to-machine integration and sequencing</li><li>Willingness to travel across Europe</li><li>PLC or C# experience is advantageous</li></ul>  For a confidential conversation about the position contact Karl on 353 86 201 1223 or klippett@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Mechatronics Engineer

Job Title:     Facilities Lead Location:    Westmeath Status:     Permanent Position Summary: <ul><li>The successful candidate will lead a small team and take responsibility for maintaining and improving the buildings, grounds, services, and facilities across the site.</li><li>This role is suited to a capable individual with a strong practical background in facilities management or a related discipline, ideally within an industrial or manufacturing environment</li></ul>  Key Responsibilities: <ul><li>Lead, develop, and support a small facilities, maintenance, and cleaning team Coordinate facility repairs, upgrades, and improvement projects</li><li>Lead facilities-related CapEx projects from planning to completion</li><li>Ensure compliance with health & safety legislation, building regulations, and environmental standards</li><li>Manage waste disposal, recycling, and sustainability initiatives</li></ul> Qualifications and Requirements: <ul><li>Practical, hands-on approach</li><li>Strong knowledge of health & safety and regulatory compliance</li><li>Alternatively, SOLAS-accredited trade certification with 5 years’ hands-on experience is desirable</li><li>Qualification or proven experience in Facilities Management, Engineering, Energy Management, or related discipline</li></ul>  For a confidential conversation about the position contact Karl on 353 86 201 1223 or klippett@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Facilities Lead

ICT Manager (Management Information Systems) Overview We are seeking an experienced ICT Manager to lead and coordinate all information systems and IT infrastructure activities within a fast-paced, high-volume manufacturing environment. This role will oversee a small IT team and ensure the reliability, security, and continuous improvement of all systems supporting business operations. The successful candidate will combine strong technical expertise with People management/Stakeholder capability and prior experience in an industrial or manufacturing setting, with a key focus on supporting production and automation systems. Key Responsibilities: <ul><li>Plan, prioritize, and manage IT support and maintenance activities to ensure optimal system performance and uptime</li><li>Lead and develop a small IT team, providing guidance, mentoring, and performance management</li><li>Oversee daily IT operations, including help desk support, IMAC/VMAC activities, and incident response</li><li>Manage and maintain IT infrastructure, including LAN/WAN networks, servers, telephony systems, desktops, printers, and scanning devices</li><li>Provide IT and technology support to production and automation lines, including troubleshooting (“firefighting”), system upgrades, and fault analysis to minimise downtime</li><li>Collaborate with cross-functional stakeholders to understand business needs and implement effective IT solutions</li><li>Evaluate, recommend, and implement hardware and software solutions to enhance system capabilities</li><li>Ensure data integrity, cybersecurity, and compliance with relevant legal and regulatory requirements</li><li>Develop and enforce IT policies, procedures, and best practices</li><li>Lead business continuity and disaster recovery planning, including system backups and recovery processes</li><li>Manage system scheduling, data storage, and retrieval functions</li><li>Provide technical leadership on medium to large-scale IT projects</li><li>Support workforce planning, including recruitment and retention of IT staff</li></ul> Requirements <ul><li>Bachelor’s degree in IT, Computer Science, or a related field (or equivalent experience)</li><li>Minimum of 6 years’ experience in IT, with proven Senior / Management responsibility</li><li>Previous experience in a manufacturing or industrial environment is essential</li><li>Experience supporting production systems, automation lines or shop-floor IT environments</li><li>Strong knowledge of IT infrastructure, including networks, servers, and end-user support</li><li>Demonstrated ability to troubleshoot complex system issues in time-critical production environments</li><li>Proven experience in system upgrades, fault diagnosis, and continuous improvement initiatives</li><li>Strong problem-solving skills and ability to work independently</li><li>Excellent communication and stakeholder management skills</li></ul> Key Competencies <ul><li>Leadership and team development</li><li>Strategic thinking and decision-making</li><li>Technical expertise across IT systems and infrastructure</li><li>Project management</li><li>Process improvement and operational efficiency</li><li>Ability to operate effectively in a fast-paced, production-driven environment</li></ul> For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

ICT Manager

Job Title:     Commercial Finance Business Partner Location:    Monaghan Status:     Contract Position Summary: <ul><li>Act as a primary link between finance and the commercial team, providing insight to support decision-making and guidance to optimise customer profitability and sales growth.</li><li>Share insights with the leadership team on retailer performance and performance to budget</li><li>Reporting to the Chief Financial Officer, the Commercial Finance Business Partner will support the commercial team to achieve objectives on volume, pricing and profitability across our key retailers.</li></ul>  Key Responsibilities: <ul><li>Act as a trusted advisor to the Commercial Director and the account managers</li><li>Assist with the budgeting process, tracking monthly on key metrics by retailer</li><li>Develop tools and dashboards to bring real clarity to monthly customer profitability</li><li>Provide financial insight guidance to support negotiations with key customers</li></ul> Qualifications and Requirements: <ul><li>Qualified Accountant</li><li>Experience within FMCG</li><li>Commercial Finance experience</li><li>Analytical and financial modelling skills</li></ul>For a confidential conversation about the position contact Karl on 353 86 201 1223 or klippett@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Commercial Finance Business Partner

We are seeking a detail-oriented and proactive Accounts Payable Specialist to join our clients growing finance team. This is an exciting opportunity to play a key role in supporting day-to-day finance operations within a fast-paced and evolving business environment. This position will take ownership of the accounts payable function while working closely with the wider finance team to support business growth and operational efficiency. Key Responsibilities: <ul><li>Manage the end-to-end accounts payable process, including verification, coding, and timely processing of invoices</li><li>Prepare and execute payment runs to vendors</li><li>Respond to vendor queries, resolve discrepancies, and maintain strong working relationships</li><li>Monitor and manage the accounts payable inbox, ensuring timely handling of all incoming invoices and requests</li><li>Process employee expense claims in line with company policies</li><li>Review and maintain the Purchase Order (PO) log to ensure accuracy and completeness</li><li>Ensure compliance with internal controls, accounting policies, and relevant tax regulations</li><li>Support month-end and year-end close processes related to accounts payable and receivable</li><li>Contribute to process improvements, system enhancements, and workflow efficiencies</li><li>Assist with finance-related projects, including ERP system implementation and business expansion initiatives</li><li>Provide ad hoc support to the wider finance team as required</li><li>Support accounts receivable activities as the role evolves</li></ul> Requirements: <ul><li>Proven experience in an Accounts Payable or Accounts Receivable role within a fast-paced environment</li><li>Strong understanding of accounts payable processes and core accounting principles</li><li>Experience working with ERP or accounting systems (e.g., QuickBooks, NetSuite, Odoo)</li><li>Excellent attention to detail with the ability to manage high volumes of transactions accurately</li><li>Strong organisational and time management skills</li><li>Ability to quickly learn new systems and processes</li><li>Effective communication skills, with the ability to engage confidently with internal stakeholders and external vendors</li><li>Self-motivated, adaptable, and able to thrive in a dynamic environment</li></ul> Desirable <ul><li>Experience working in a start-up or high-growth environment</li><li>Exposure to the medical devices or similar regulated industry</li><li>Experience with SAP Concur or similar expense management systems</li><li>Accounts Receivable experience</li></ul> For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Accounts Payable Specialist

Senior Manufacturing Supervisor – Medical Devices About the Role We are currently recruiting on behalf of our client for an experienced Senior Manufacturing Supervisor to lead operations within a regulated medical device environment. This is a key leadership role responsible for driving production performance, ensuring regulatory compliance, and developing high-performing teams in a fast-paced manufacturing setting. Key Responsibilities <ul><li>Lead daily manufacturing operations to achieve targets across safety, quality, delivery, and cost</li><li>Supervise and develop production teams including supervisors, team leads, trainers, and operators</li><li>Coordinate production planning to meet customer demand</li><li>Ensure full compliance with GMP, ISO 13485, and FDA regulations</li><li>Partner with Engineering, Quality, and Supply Chain to resolve issues and improve processes</li><li>Drive continuous improvement initiatives using Lean and Six Sigma methodologies</li><li>Monitor KPIs and implement corrective actions where required</li><li>Support new product introductions (NPI) and technology transfers</li><li>Maintain accurate documentation and ensure product traceability</li><li>Lead internal and external audits related to production</li><li>Manage staffing levels and resource planning based on demand</li><li>Conduct regular Gemba walks to ensure adherence to Health & Safety, Quality, and operational standards</li></ul> Requirements <ul><li>Bachelor’s degree in Engineering, Manufacturing, or a related discipline</li><li>5 years’ experience in a medical device or highly regulated manufacturing environment</li><li>Strong knowledge of GMP, ISO 13485, and FDA requirements</li><li>Proven leadership experience with the ability to develop and motivate teams</li><li>Experience with Lean Manufacturing, Six Sigma, or continuous improvement tools</li><li>Excellent communication, problem-solving, and organisational skills</li></ul> Desirable <ul><li>Experience with ERP systems such as SAP, Oracle, or IFS</li><li>Exposure to advanced manufacturing technologies</li><li>Strong interpersonal skills with the ability to influence and drive change</li></ul> For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Senior Supervisor

Quality Engineer - Contract Role Location: Client Medical Device Manufacturing Site Shift: Primarily Day Shift (Flexibility Required for Occasional Evening Shifts) Contract Type: Contract Position Job Summary The Quality Engineer will ensure that all products manufactured at the client’s medical device site comply with approved specifications and that all site activities adhere to current Good Manufacturing Practice (cGMP) and applicable regulatory requirements. Working as part of the Quality Team, the successful candidate will support the achievement of quality objectives and ensure ongoing compliance with internal procedures and external regulatory standards. Key Responsibilities <ul><li>Coordinate assigned elements of the Quality Management System (QMS), ensuring full compliance across site operations</li><li>Participate in internal and external quality audits as required</li><li>Support the investigation of customer complaints and implement effective corrective and preventive actions (CAPA)</li><li>Manage day-to-day CAPA activities, ensuring timely initiation, investigation, and closure</li><li>Monitor and report on Quality System performance metrics for management review</li><li>Deliver quality-related training to site personnel as required</li><li>Escalate quality system failures and support implementation of corrective actions and product containment</li><li>Verify effectiveness of corrective and preventive actions</li><li>Ensure compliance with all applicable regulatory requirements (e.g., ISO, FDA)</li><li>Support validation activities across manufacturing processes</li><li>Maintain accurate, complete, and compliant Quality System documentation</li><li>Review lot/batch records and perform product release activities</li><li>Inspect incoming materials and support supplier quality management</li><li>Perform in-process and final product testing in line with approved specifications</li><li>Participate in continuous improvement initiatives across quality, safety, and production systems</li><li>Support risk management activities as required</li></ul> Essential Requirements <ul><li>Degree in Engineering, Science, Quality, or a related discipline</li></ul> Desirable Requirements <ul><li>Lean Six Sigma Green Belt or equivalent statistical knowledge</li><li>Experience in injection moulding or tooling environments</li></ul> Experience Required <ul><li>Minimum 2 years’ experience working within a Quality function in a highly regulated medical device or combination product manufacturing environment</li><li>Working knowledge of quality system regulations such as ISO 13485, ISO 9000, and/or FDA 21 CFR Part 820</li><li>Experience with key quality system elements such as CAPA, auditing, validation, and design controls</li></ul> Key Skills & Competencies <ul><li>Strong attention to detail with a high level of accuracy</li><li>Proven problem-solving and analytical skills</li><li>Ability to adapt to changing processes and priorities</li><li>Strong technical aptitude within a manufacturing environment</li><li>Commitment to quality, compliance, and safety</li><li>Ability to work independently with a high level of initiative</li></ul> For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Quality Engineer

Role Overview We are seeking an experienced and motivated OpEx Business Analyst to join our clients global Operational Excellence team. This role focuses on designing, developing, and maintaining interactive dashboards and data-driven solutions to support business optimisation initiatives. The successful candidate will play a key role in transforming complex data into clear, actionable insights using modern digital tools, primarily Microsoft Power BI and the wider Microsoft Power Platform ecosystem. You will collaborate with cross-functional teams across Dublin, Puerto Rico, and the US to support data-driven decision-making and continuous improvement initiatives. Key Responsibilities <ul><li>Gather and translate stakeholder requirements into effective dashboard and reporting solutions.</li><li>Design, develop, and maintain interactive dashboards using Power BI and other approved digital tools.</li><li>Build and manage data models, integrating multiple data sources such as SQL Server, SharePoint, and Dataverse.</li><li>Apply data visualization best practices to present insights clearly, including drill-throughs and advanced analytics.</li><li>Collaborate with business users, data analysts, and IT teams to ensure accuracy and consistency of data.</li><li>Optimise dashboards for performance, usability, and scalability.</li><li>Publish and maintain reports and dashboards for stakeholder access.</li><li>Provide training and support to end users on dashboard usage and interpretation.</li><li>Support automation and process improvement initiatives using Power Platform tools</li></ul>Experience <ul><li>Minimum 18 months’ experience in a similar data/digital role.</li><li>Strong experience with Microsoft Power BI.</li><li>Working knowledge of PowerApps, Power Automate, and Dataverse.</li><li>Experience with SQL Server and relational databases.</li><li>Familiarity with SharePoint and data integration techniques.</li><li>Knowledge of JSON, HTML, and basic C .</li><li>Experience using development tools such as Visual Studio Code or Visual Studio.</li><li>Exposure to Power Platform CLI.</li><li>Programming experience in one or more: JavaScript, TypeScript, React JS, Python.</li></ul> Deliverables <ul><li>Operational metrics dashboards</li><li>Balanced scorecard reports</li><li>Qualification and compliance reports</li><li>Automation usage and performance dashboards</li><li>Integrated survey and reporting tools</li><li>Training materials and end-user support sessions</li></ul> For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Business Analyst - OpEx

QA Validation Engineer Department: Quality Reporting to: Validation Team Lead Overview We are seeking a QA Validation Engineer to support the site validation program, ensuring compliance with regulatory, quality, and cGMP standards within a biopharmaceutical manufacturing environment. Key Responsibilities <ul><li>Support and execute validation activities for equipment, utilities, processes, and systems</li><li>Develop and maintain:<ul><li>Validation Master Plan (VMP)</li><li>Project validation plans and schedules</li></ul></li><li>Generate and execute:<ul><li>Validation protocols (IQ/OQ/PQ)</li><li>Final reports and investigations</li></ul></li><li>Manage change control, deviations, and CAPA processes</li><li>Review and approve validation and quality documentation</li><li>Ensure all activities are completed in line with cGMP and regulatory requirements</li><li>Support audits (internal and external)</li><li>Contribute to continuous improvement initiatives across quality and manufacturing</li><li>Maintain compliance across production areas and support cross-functional teams</li></ul>Requirements <ul><li>Degree in Engineering or a scientific discipline</li><li>Minimum 3 years’ experience in validation within a regulated (biopharma/pharma) environment</li><li>Strong knowledge of:<ul><li>cGMP</li><li>Validation lifecycle (IQ/OQ/PQ)</li><li>Regulatory standards (FDA / EU GMP / GAMP)</li></ul></li><li>Excellent communication, organisation, and problem-solving skills</li><li>Ability to work independently and within cross-functional teams</li></ul>Key Competencies <ul><li>Strong attention to detail with a Right First Time mindset</li><li>Ability to manage multiple priorities and meet deadlines</li><li>Proactive approach to issue resolution and compliance</li></ul>Additional Information <ul><li>High level of autonomy with responsibility for delivering validation activities</li><li>Regular interaction with internal teams and external auditors</li><li>Commitment to maintaining safety, quality, and compliance standards at all times</li></ul>

QA Validation Engineer

Project (Automation) Engineer Location: Westport Duration: 12-month initial contract (with strong extension potential) Overview We are seeking a Project (Automation) Engineer to support a large-scale Electronic Batch Record (EBR) implementation project within a pharmaceutical manufacturing environment. This role will focus on transitioning plant operations from traditional paper-based batch records to fully digital EBR systems, working as part of a cross-functional automation project team. Key Responsibilities <ul><li>Lead scoping and requirements definition for EBR implementation across manufacturing areas</li><li>Assess equipment readiness and identify requirements for EBR conversion</li><li>Define scope for:<ul><li>Software upgrades</li><li>PLC network cards</li><li>Operator interfaces (PC carts, tablets)</li><li>WiFi access points, LAN infrastructure, and power requirements</li></ul></li><li>Develop cost estimates, including installation and potential qualification activities</li><li>Prepare and present project scope, timelines, and budgets to stakeholders</li><li>Raise purchase orders and coordinate with vendors and contractors</li><li>Work closely with Production to plan access for installation and upgrades</li><li>Act as Permit Requester, ensuring:<ul><li>Risk assessments</li><li>Method statements</li><li>EHS compliance</li></ul></li></ul>Automation & Systems Integration <ul><li>Assess and scope connectivity to the Manufacturing Control Network (MCN)</li><li>For networked equipment:<ul><li>Identify required data fields from PLC/SCADA systems</li><li>Support integration into OSIsoft PI System</li><li>Collaborate with Automation/OT teams to ensure data availability for MES/EBR configuration</li></ul></li><li>Liaise with vendors to obtain and manage PLC/SCADA data tags</li></ul>Project Delivery & Compliance <ul><li>Support engineering lifecycle documentation and system updates</li><li>Participate in project reviews and technical documentation</li><li>Execute engineering activities related to change control processes</li><li>Ensure compliance with GMP and regulated environment standards</li></ul>Key Requirements <ul><li>Degree in Engineering (Automation, Electrical, Chemical, or related discipline)</li><li>Experience in pharmaceutical or regulated manufacturing environments</li><li>Strong background in:<ul><li>Automation systems (PLC/SCADA)</li><li>MES / EBR projects (preferred)</li><li>Industrial networking and system integration</li></ul></li><li>Proven experience in:<ul><li>Project engineering or project delivery</li><li>Vendor and contractor coordination</li><li>Costing, scheduling, and scope management</li></ul></li><li>Familiarity with data historians and manufacturing systems integration is an advantage</li></ul>Desirable <ul><li>Experience with EBR/MES platforms (e.g., POMS)</li><li>Knowledge of validation / qualification processes (CSV)</li><li>Understanding of GMP and change control systems</li></ul>

Project Automation Engineer

Quality Technician We are currently seeking a Quality Technician to join a dynamic and growing team within a highly regulated medical device manufacturing environment. This is an excellent opportunityis an initial 6-Month Contract (with view to extension) and would suit a detail-oriented professional who will contribute to quality excellence and continuous improvement initiatives. Key Responsibilities: <ul><li>Perform incoming, in-process, and final product inspections/testing in line with approved procedures and specifications</li><li>Ensure all activities are fully compliant with cGMP, ISO, and regulatory requirements</li><li>Support operations across Quality Control (QC), Incoming Quality Assurance (IQA), and Metrology areas</li><li>Maintain accurate and compliant quality documentation and records</li><li>Identify, report, and escalate quality issues or potential risks in a timely manner</li><li>Participate in internal audits and support audit readiness activities</li><li>Assist with change control processes, including documentation updates</li><li>Generate and report quality metrics for management review</li><li>Support batch record preparation and manufacturing documentation</li><li>Make disposition decisions on incoming materials</li><li>Contribute to continuous improvement initiatives across quality, safety, and production</li></ul> Requirements: <ul><li>Third-level qualification in a relevant scientific or technical discipline (desirable)</li><li>1–2 years’ experience in a GMP-regulated environment (medical devices, pharma, or similar)</li><li>Experience working within a quality system in a regulated manufacturing environment</li><li>Strong understanding of GMP, ISO, and regulatory standards</li></ul> Key Skills & Competencies: <ul><li>Exceptional attention to detail and accuracy</li><li>Strong problem-solving and analytical skills</li><li>Ability to work independently and as part of a team</li><li>Adaptable and comfortable working in a fast-paced, regulated environment</li><li>Strong commitment to quality, compliance, and safety</li></ul> For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Quality Technician

Project (Automation) Engineer We are currently seeking an experienced Project (Automation) Engineer to join a dynamic and growing engineering team. This is an exciting opportunity to work on a range of high-impact projects involving automation, aseptic processing, and manufacturing equipment within a regulated environment. Key Responsibilities: <ul><li>Coordinate the delivery of processing equipment to site in line with project scope and timelines</li><li>Oversee equipment installation and service hook-ups in collaboration with vendors and engineering teams</li><li>Support or lead Factory Acceptance Testing (FAT) activities</li><li>Ensure all equipment documentation is completed and maintained</li><li>Commission equipment in preparation for validation activities</li><li>Develop training materials and maintenance protocols</li><li>Report project progress and provide technical support to the Project Manager</li><li>Contribute to cross-functional problem-solving in manufacturing, aseptic processing, and packaging</li><li>Drive process improvement initiatives across the business</li><li>Lead project review meetings and participate in regular operational and departmental meetings</li></ul> Requirements: <ul><li>Degree qualification in Engineering, Automation, Science, or a related discipline</li><li>Minimum of 5 years’ experience in a relevant engineering role</li><li>Experience in medical device or pharmaceutical industries is advantageous but not essential</li><li>Project management experience is desirable</li><li>Strong interpersonal skills with the ability to work in cross-functional teams</li><li>Ability to work independently and manage multiple priorities</li></ul> Skills & Experience: <ul><li>Strong organisational and time management skills</li><li>Experience working on equipment or process-related projects</li><li>Exposure to regulated environments (GxP/GMP) preferred</li><li>Familiarity with manufacturing systems</li><li>Knowledge of PLC and SCADA systems</li><li>Proficient in Microsoft Office and Windows platforms</li><li>Flexible approach to support production needs when required</li><li>Willingness to learn and adapt to new technologies</li></ul> For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Project Engineer III

Documentation Specialist (Laboratory) We are seeking a detail-oriented Documentation Specialist to support laboratory operations in a regulated environment. This role is critical in ensuring documentation meets GMP/GDP compliance and is delivered on time to support manufacturing and quality objectives. Key Responsibilities:  <ul><li>Coordinate review and approval of laboratory documentation (SOPs, logbooks, forms)</li><li>Ensure documents progress efficiently through approval workflows in line with timelines</li><li>Maintain and manage documentation within electronic systems</li><li>Act as a key point of contact for document status and process queries</li><li>Support laboratory readiness for NPI, Tech Transfer, and routine manufacturing</li><li>Review, edit, and format documents to ensure accuracy and compliance (GMP/GDP)</li><li>Track and report on documentation metrics and performance</li><li>Participate in investigations, root cause analysis, and continuous improvement initiatives</li><li>Collaborate cross-functionally to ensure consistency and compliance</li></ul> Requirements:  <ul><li>Bachelor’s degree (preferably in Science or related field)</li><li>1 year experience in a regulated laboratory or document control environment</li><li>Strong knowledge of GMP/GDP standards</li><li>Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, Visio</li><li>Experience with electronic document management systems preferred</li><li>Excellent attention to detail, organisation, and communication skills</li><li>Ability to work in a fast-paced, deadline-driven environment</li></ul> For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Documentation Specialist

We are seeking a motivated and detail-oriented QC Analyst to join a dynamic analytical laboratory team operating within a regulated environment. This role is ideal for someone with hands-on laboratory experience who is passionate about quality, data integrity, and continuous improvement. You will play a key role in ensuring timely and compliant analytical testing, supporting investigations, and driving operational excellence within the lab. Key Responsibilities:  <ul><li>Ensure laboratory documentation and computerized systems comply with Data Integrity and regulatory requirements</li><li>Perform and complete analytical testing in line with agreed schedules</li><li>Support and guide team members to ensure high standards of test execution and performance</li><li>Drive continuous improvement initiatives to enhance laboratory efficiency and productivity</li><li>Monitor testing schedules and implement recovery plans where required</li><li>Identify performance gaps and collaborate with management on corrective actions</li><li>Initiate and support Out of Specification (OOS) investigations in a timely manner</li><li>Maintain accurate, complete, and compliant laboratory records</li><li>Ensure laboratory equipment is properly used, calibrated, and maintained</li><li>Promote a strong quality culture and adherence to 5S standards</li><li>Investigate documentation-related events with potential quality or compliance impact</li><li>Participate in or lead investigation activities such as root cause analysis</li><li>Collaborate cross-functionally and communicate technical information effectively</li><li>Ensure compliance with internal procedures and all applicable regulatory standards</li></ul> Requirements:  <ul><li>Bachelor’s degree (or equivalent) in a Science or related discipline (preferred)</li><li>Minimum 1 years’ experience in an analytical or QC laboratory role</li><li>Experience working in a GLP/GMP-regulated environment</li><li>Strong knowledge of EU, FDA, ICH, and HPRA guidelines</li><li>Hands-on experience with analytical instrumentation (e.g., UHPLC, SoloVPE, TOC)</li><li>Proven ability to troubleshoot laboratory equipment and methods</li><li>Strong attention to detail with excellent problem-solving skills</li><li>Effective communication and teamwork abilities</li></ul> For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

QC Analytical Analyst

Research Scientist Role Overview Hands-on, research-focused role responsible for generating preclinical and clinical evidence to support medical device development. The position centres on experimental design, data analysis, and scientific publication, with a strong emphasis on translating research into clinical impact. Key Responsibilities Research & Evidence Generation <ul><li>Design, execute, and analyse preclinical experiments</li><li>Conduct in-vitro and benchtop testing (e.g., occlusion models)</li><li>Maintain accurate, compliant experimental records and datasets</li><li>Interpret results and communicate findings to internal and clinical teams</li></ul>Scientific Communication <ul><li>Lead and support preparation of peer-reviewed publications</li><li>Contribute to clinical research activities (first-in-human and post-market studies)</li><li>Present findings internally and at external conferences</li><li>Support scientific content for training and commercial activities</li></ul>Collaboration <ul><li>Work closely with multidisciplinary teams and clinical collaborators</li><li>Align research activities with clinical and product needs</li><li>Support conference preparation and coordination</li></ul>Additional Responsibilities <ul><li>Manage research and demonstration devices</li><li>Support sourcing of materials and test equipment</li><li>Provide general scientific and operational support to R&D and clinical teams</li></ul>Required Qualifications & Experience <ul><li>MSc or PhD in Biomedical Engineering, Life Sciences, or related field</li><li>Strong experience in experimental design, execution, and data analysis</li><li>Proven scientific writing skills (peer-reviewed publications preferred)</li><li>Excellent organisational and documentation skills</li><li>Strong communication and teamwork abilities</li></ul>Desirable Experience <ul><li>In-vitro / benchtop model development (cardiovascular or neurovascular preferred)</li><li>Knowledge of stroke or neurovascular therapies</li><li>Experience working with clinicians or clinical research teams</li><li>Conference presentation experience</li><li>Familiarity with regulated medical device environments</li></ul>

Reserach Scientist

Project Manager (Contract)  New Connectivity Product Development A growing technology company that develops hardware, software, and connected solutions for safer, healthier, and more sustainable homes is seeking an experienced Project Manager (Contract) to lead the development of a new connectivity product. This organization delivers trusted solutions that help people live independently and safely in their homes. As the company continues to expand its product portfolio, this role will play a key part in bringing innovative products from initial concept through to market launch. This is a daily rate contract position, requiring a highly experienced professional with strong technical and product development expertise.   Key Responsibilities <ul><li>Lead the end-to-end project management of a new connected product solution.</li><li>Manage product development from concept, feasibility, research & development, prototyping, and manufacturing through to market launch.</li><li>Coordinate cross-functional teams including engineering, hardware, software, and manufacturing.</li><li>Support technical feasibility assessments and early-stage product concept development.</li><li>Work closely with external contractors, suppliers, and manufacturing partners.</li><li>Monitor project timelines, budgets, risks, and deliverables.</li><li>Ensure alignment between technical development, product strategy, and commercial launch plans.</li><li>Provide strong leadership and clear communication across internal and external stakeholders.</li></ul>  Required Experience <ul><li>Proven Project Management experience delivering electronic products.</li><li>Demonstrated experience managing electronics-based product development from concept through to launch.</li><li>Strong Research & Development (R&D) background.</li><li>Experience working with hardware and electronics engineering teams.</li><li>Strong engineering understanding or technical aptitude.</li><li>Experience managing large, complex projects with multiple stakeholders.</li><li>Experience working with external contractors and manufacturing partners.</li></ul>  Skills & Attributes <ul><li>Self-starter with strong initiative and ownership.</li><li>Excellent leadership and stakeholder management skills.</li><li>Strong analytical and problem-solving abilities.</li><li>Highly organized with strong project planning capability.</li><li>Comfortable working in a fast-paced, innovative environment.</li></ul>  Working Arrangements <ul><li>Daily rate contract position.</li><li>Flexibility required to attend sites and offices across the UK when needed.</li><li>Opportunity to work on innovative technology that improves safety, health, and sustainability in the home.</li></ul>

Project Manager

Senior Design Assurance Quality Engineer Role Summary The purpose of this role is to provide Design Control and Quality Engineering support for medical device products within a manufacturing environment. The position supports product development, regulatory compliance, and manufacturing quality, contributing to the successful commercialization of products and overall business growth. Key Responsibilities Design Assurance & New Product Development <ul><li>Act as the Quality representative and core team member on New Product Commercialization (NPC) projects.</li><li>Lead and support Design Control activities, ensuring compliance with applicable regulatory and quality standards.</li><li>Facilitate risk management activities, including Risk Assessments and Design Failure Mode and Effects Analysis (DFMEA).</li><li>Support the development and review of product specifications, engineering drawings, and technical documentation.</li></ul>Process & Manufacturing Support <ul><li>Contribute to Process Failure Mode and Effects Analysis (PFMEA) and process validation activities for new product introduction projects.</li><li>Provide quality guidance and oversight during product and process development.</li></ul>Quality Systems & Compliance <ul><li>Perform internal audits in accordance with the annual audit schedule to ensure compliance with ISO 13485 and FDA Quality System Regulations (QSR).</li><li>Ensure design and development activities meet all applicable regulatory and quality requirements.</li></ul>Problem Solving & Continuous Improvement <ul><li>Support Corrective and Preventive Action (CAPA) investigations and implement effective solutions related to new product projects and manufacturing processes.</li><li>Perform statistical analysis to support validation activities and continuous improvement initiatives.</li></ul>Training & Support <ul><li>Provide training and guidance to personnel on quality procedures, design controls, and regulatory requirements as required.</li></ul>Experience Requirements <ul><li>5–8 years of experience in the medical device industry.</li><li>Demonstrated experience with:<ul><li>Design Controls</li><li>New Product Introduction (NPI/NPC)</li><li>Statistical analysis</li><li>Process validation</li></ul></li></ul>Education & Qualifications <ul><li>Bachelor’s degree in Engineering or a related Science discipline.</li><li>Professional quality qualification preferred, such as Certified Quality Engineer (CQE).</li><li>Experience working in regulated environments aligned with ISO 13485 and FDA requirements.</li></ul>

Senior Design Assurance Engineer

Design Assurance Manager – Galway Role Summary The Design Assurance Manager is responsible for ensuring medical devices are designed and developed in compliance with applicable regulatory requirements and quality standards. This role provides leadership across design controls, risk management, and verification and validation activities throughout the product lifecycle, while partnering closely with cross-functional teams. Key Responsibilities <ul><li>Own and maintain design control processes in compliance with ISO 13485, EU MDR, and FDA 21 CFR 820.</li><li>Ensure complete and compliant Design History Files (DHF) and design documentation.</li><li>Lead risk management activities in accordance with ISO 14971.</li><li>Oversee design verification and validation, including usability engineering where applicable.</li><li>Support design transfer to manufacturing and related validation activities.</li><li>Provide design assurance input to design changes, CAPAs, complaints, and post-market activities.</li><li>Support regulatory submissions and audits (Notified Body, FDA, internal).</li></ul>Qualifications & Experience <ul><li>Bachelor’s degree in Engineering, Science, or related field.</li><li>5 years experience in design assurance, quality, or regulatory roles within the medical device industry.</li><li>Strong working knowledge of ISO 13485, ISO 14971, EU MDR, and FDA design controls.</li><li>Experience supporting audits and regulatory submissions.</li></ul>Key Skills <ul><li>Strong attention to detail and documentation skills</li><li>Effective cross-functional communication</li><li>Risk-based decision making</li><li>Ability to work independently in a regulated environment</li></ul>

Design Assurance Manager

About the Role An established manufacturing company is seeking an experienced NPI & Quotation Engineer to join the team at its facility in Shannon, Co. Clare. In this key role, you will act as the link between customer requirements and production planning, ensuring accurate quotations and supporting efficient communication between internal teams and suppliers. About the Company The company specializes in the manufacture of precision metal components and assemblies tailored to meet exact customer specifications. With a skilled workforce and a strong reputation for quality, the organisation delivers high-quality manufacturing solutions to clients worldwide. Operating under ISO9001 and AS9100 quality standards, the company maintains rigorous processes and industry best practices to ensure the highest levels of performance and customer satisfaction. Key Responsibilities <ul><li>Translate customer information into practical working formats for the quotation office</li><li>Prepare Bills of Materials (BOMs) and component specifications using Excel for supplier distribution</li><li>Respond to supplier queries regarding parts and specifications</li><li>Collaborate with Finance, NPI, and Engineering teams to develop and improve labour costings</li><li>Monitor labour efficiency against quoted timelines</li><li>Develop and implement effective costing models</li><li>Work closely with the Sales team and customers to deliver quotations in a timely and professional manner</li><li>Monitor foreign exchange (FX) rates to ensure accurate cost projections</li><li>Interpret and understand detailed engineering drawings</li><li>Liaise with suppliers to track and manage component costs</li><li>Maintain and oversee the Approved Vendor List (AVL)</li><li>Upload and maintain BOMs and routers within the ERP system</li><li>Provide administrative support to both the Sales and Engineering teams</li></ul> Requirements <ul><li>Engineering background is essential</li><li>Sheet metal manufacturing experience is essential</li><li>Experience in cost modelling and supplier management is advantageous</li><li>Finance or costing experience is desirable</li><li>Strong analytical and organisational skills</li><li>Advanced Excel skills and experience with ERP systems</li><li>Ability to interpret engineering drawings</li><li>Excellent communication and problem-solving abilities</li><li>Previous experience in NPI (New Product Introduction) or quotation engineering roles is highly desirable</li></ul> For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

NPI & Quotation Engineer

Job Overview: We are seeking a skilled Manufacturing Execution Systems (MES) Specialist to support the design, implementation, and continuous improvement of MES recipes and system processes. The successful candidate will ensure compliance with regulatory, quality, safety, and operational standards while supporting manufacturing and new product introduction activities. Key Responsibilities: <ul><li>Design, develop, and maintain POMSnet MES recipes and system configurations.</li><li>Manage and implement MES system changes aligned with business and operational objectives.</li><li>Support SAP and MES strategy implementation within manufacturing operations.</li><li>Ensure MES processes, SOPs, policies, and training materials comply with current safety, quality, and IT standards.</li><li>Review and manage business and system risks associated with MES and recipe changes.</li><li>Support timely and compliant qualification of MES recipes, upgrades, and system enhancements.</li><li>Act as local key user (LKU) for SAP and MES systems, supporting material and system queries.</li><li>Participate in project activities from initiation through implementation to ensure system and hardware requirements are addressed.</li><li>Troubleshoot and resolve MES, recipe, and system-related issues in collaboration with cross-functional teams.</li><li>Prepare and present project and system status reports.</li><li>Participate in Technical Review Boards and support identification of issues, workarounds, and system fixes.</li><li>Support regulatory audits and inspections from authorities and customers.</li><li>Promote a culture of right-first-time performance and continuous improvement.</li><li>Participate in MES knowledge sharing and cross-site collaboration initiatives</li></ul>Qualifications & Experience: <ul><li>Third level qualification in Science, Engineering, IT, or a related discipline (Certificate, Diploma, or Degree).</li><li>Minimum of 3 years’ experience working in a regulated manufacturing environment (FDA/HPRA or equivalent).</li><li>Strong knowledge of cGMP and pharmaceutical regulatory requirements.</li><li>Experience working with MES systems (POMSnet or similar platforms preferred).</li><li>Experience supporting SAP systems is advantageous.</li></ul>Skills & Competencies:  <ul><li>Strong technical and problem-solving abilities.</li><li>Excellent organisational and time management skills.</li><li>Ability to manage multiple priorities in a fast-paced manufacturing environment.</li><li>Strong communication and interpersonal skills with the ability to collaborate across teams.</li><li>High level of integrity and strong work ethic.</li><li>Demonstrated ability to drive performance improvement initiatives.</li></ul> For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

MES Engineer

Engineering Technician – Moulding & Assembly Key Responsibilities <ul><li>Support Moulding/Tooling and Assembly operations in line with safety and regulatory requirements.</li><li>Ensure daily production targets are achieved in partnership with Operations</li><li>Perform routine maintenance, troubleshooting, and repairs on:<ul><li>Injection moulding machines and tooling</li><li>Automated and semi-automated assembly equipment</li><li>Electrical, mechanical, and control systems</li></ul></li><li>Act as Subject Matter Expert for assigned equipment and processes.</li><li>Perform equipment calibration and maintain maintenance/calibration systems.</li><li>Interpret electrical and mechanical drawings to support fault finding and improvements.</li><li>Fabricate ad hoc mechanical/electrical components for repairs and upgrades.</li><li>Participate in continuous improvement and site maintenance excellence initiatives.</li><li>Complete documentation, commissioning, and validation activities in compliance with cGMP.</li><li>Execute all maintenance work through the Maximo management system.</li><li>Support operational and strategic technical projects as required.</li></ul> Requirements <ul><li>Leaving Certificate, Senior Trade Certificate, or FETAC Level 6 (or working toward same).</li><li>Minimum 3 years’ experience in high-precision manufacturing.</li><li>Minimum 2 years’ experience in a regulated manufacturing environment.</li><li>Experience in one or more of the following:<ul><li>Mould tooling</li><li>Electrical systems</li><li>Automation</li></ul></li><li>Strong problem-solving skills with complex equipment.</li><li>Proficient in computer-interfaced equipment and ERP systems.</li></ul> For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Engineering Technician

Principal Researcher – Advanced Research Centre Overview <ul><li>We are seeking a highly experienced Principal Researcher to play a key leadership role within a newly established Advanced Research Centre. This is a senior individual contributor position focused on bridging the gap between cutting-edge research and real-world industrial application.</li><li>The successful candidate will lead internally driven research initiatives while also representing the organisation in external collaborative research programs. The role will focus on developing technologies and capabilities in sensors, connected technologies, and advanced electronics, ensuring research activities align with long-term technology strategy and future product opportunities.</li><li>This is a permanent industry position, not a fixed-term academic appointment.</li></ul> Key Responsibilities Internal Research & Advanced Technology Development <ul><li>Define, initiate, and lead internally driven research projects aligned with long-term technology strategy</li><li>Explore early-stage and exploratory technologies to build organisational knowledge and technical capability</li><li>Document, communicate, and present research outcomes to internal stakeholders including R&D, product development, and strategy teams</li></ul> External Collaboration & Research Leadership <ul><li>Establish and lead collaborative research relationships with universities, research institutes, and global technology partners</li><li>Define and shape joint research projects aligned with strategic technology roadmaps</li><li>Act as the industry technical lead on collaborative research initiatives, ensuring commercial and practical relevance</li></ul> Technology Scouting & Innovation <ul><li>Identify emerging and exploratory technologies suitable for research investment</li><li>Maintain a strong focus on:<ul><li>Sensor technologies</li><li>Connected and IoT systems</li><li>Advanced electronics and embedded platforms</li></ul></li><li>Translate technology trends into clear research opportunities and project proposals</li><li>Monitor startups, spin-outs, and early-stage technology companies for partnership opportunities</li></ul> Supplier & Ecosystem Engagement <ul><li>Collaborate with key suppliers and innovation centres to support next-generation technology development</li><li>Leverage external technology roadmaps to accelerate research and prototyping activities</li><li>Build and maintain a strong external innovation network across academia, industry, and suppliers</li></ul> Research Funding Support <ul><li>Support identification of appropriate funding mechanisms for collaborative research projects</li><li>Provide technical input to funding proposals and project scoping where required</li></ul> Internal Collaboration & Leadership <ul><li>Work closely with cross-functional teams to ensure research activities support business and product needs</li><li>Mentor and support other researchers as the research centre expands</li></ul> Essential Qualifications & Experience <ul><li>PhD in Electronics, Electrical Engineering, Physics, Materials Science, or a related discipline</li><li>Research experience in academic and/or industrial environments</li><li>Strong technical background in sensors, connected technologies, electronics, or related fields</li><li>Proven experience leading research initiatives or collaborative research programs</li><li>Demonstrated ability to operate within mixed academic–industrial research environments and deliver practical commercial outcomes</li></ul> Desirable Skills <ul><li>Strong stakeholder management and collaboration skills</li><li>Ability to identify high-impact research opportunities from emerging technology trends</li><li>Excellent communication and presentation skills, with ability to influence both technical and non-technical audiences</li><li>Strategic thinker with a practical, industry-focused mindset</li><li>Comfortable working autonomously in a senior individual contributor role</li><li>Willingness to travel for partner engagement, conferences, and research collaboration meetings</li></ul> For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Principal Researcher

Industry Standards Lead Overview <ul><li>We are seeking an experienced and strategic technical professional to join a leading organisation within the life safety electronics sector as an Industry Standards Lead.</li><li>This is a high-impact role responsible for actively shaping, influencing, and implementing global product standards. The successful candidate will represent the organisation in international standards bodies and technical committees while ensuring products meet and exceed regulatory and compliance requirements worldwide.</li><li>This position offers a unique opportunity to influence emerging regulations, contribute to global standardisation initiatives, and support the development of innovative, safety-critical electronic products.</li></ul> Key Responsibilities Standards Development & Representation <ul><li>Represent the organisation at international standards bodies, technical committees, and working groups</li><li>Contribute technical expertise and industry insight to the development of new and evolving product standards</li><li>Influence emerging regulations and ensure organisational interests are effectively represented</li><li>Build and maintain strong relationships with regulatory authorities and industry stakeholders</li></ul> Standards Monitoring & Impact Analysis <ul><li>Maintain up-to-date knowledge of global product standards, regulations, and directives relevant to life safety and electronic products</li><li>Track proposed changes and emerging requirements, including cybersecurity, wireless communications, and radio equipment directives</li><li>Assess and communicate the impact of regulatory developments on current and future product portfolios</li></ul> Product Development & Compliance Support <ul><li>Provide clear guidance to R&D, engineering, product development, and quality teams on interpretation and implementation of standards</li><li>Support product design, development, and validation activities to ensure compliance with applicable regulations</li><li>Assist in preparing technical documentation for certification, regulatory submissions, and audits</li></ul> Industry Insight & Continuous Improvement <ul><li>Monitor industry trends and best practices to proactively identify opportunities to influence standards development</li><li>Maintain an internal knowledge base of standards and regulatory updates</li><li>Deliver training and updates to internal stakeholders on relevant developments</li><li>Recommend improvements to internal processes to strengthen proactive compliance and strategic standards engagement</li></ul> Essential Qualifications & Experience <ul><li>Degree in Engineering or a related technical discipline</li><li>Strong understanding of global product standards and regulatory frameworks for electronics or safety-critical products</li><li>Proven experience representing an organisation in standards bodies, technical committees, or regulatory forums</li><li>Knowledge of emerging standards such as:</li><li>Cybersecurity standards (e.g., ETSI, IEC, ISO/IEC 27000 series)</li><li>Radio Equipment Directive (RED), FCC requirements</li><li>Wireless communication standards (e.g., ETSI EN 300 series or similar)</li><li>Excellent analytical and problem-solving skills</li><li>Strong written and verbal communication skills</li></ul> Desirable Attributes <ul><li>Ability to interpret complex technical standards and translate them into practical guidance</li><li>Strategic mindset with a proactive approach to influencing regulatory development</li><li>High attention to detail with a strong commitment to quality and compliance</li><li>Ability to collaborate effectively across R&D, product, quality, and regulatory functions</li><li>Confident rpresenting the organisation at international forums</li></ul> This is an exciting opportunity for a standards professional who is passionate about shaping the future of safety-critical electronics and influencing global regulatory frameworks. For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Industry Standards Lead

Quality Manager – New Product Introduction (NPI) Role Overview The Quality Manager – NPI is responsible for driving quality excellence across all departments involved in New Product Introduction processes. This role ensures full regulatory compliance, robust quality system implementation, and strong cross-functional collaboration to support successful product launches in a regulated environment. Key Responsibilities Leadership & Team Developme <ul><li>Lead and develop direct reports within the Regulatory and Manufacturing Quality teams supporting NPI projects.</li><li>Ensure team members receive appropriate training, resources, and mentorship to perform effectively.</li><li>Foster a culture of quality, accountability, and continuous improvement.</li></ul> Quality Systems & Complianc <ul><li>Design, implement, and maintain robust quality systems and procedures tailored to NPI requirements.</li><li>Ensure full alignment with FDA regulations, ISO standards, and internal QMS requirements.</li><li>Guarantee compliance with product development protocols and design controls during NPI activities.</li><li>Track, monitor, and audit quality-related NPI activities onsite.</li></ul> Regulatory & Cross-Functional Collaboratio <ul><li>Collaborate cross-functionally to support regulatory strategies for new product introductions.</li><li>Assess regulatory requirements for newly developed or modified products within NPI scope.</li><li>Ensure adherence to all applicable regulatory requirements for NPI projects.</li></ul> Issue Resolution & Continuous Improvemen <ul><li>Champion quality representation throughout the lifecycle of new product launches and improvements to existing products.</li><li>Address customer complaints and queries related to NPI products, ensuring timely and thorough resolution.</li><li>Initiate and manage non-conformance reports (NCRs) and CAPAs arising from NPI activities.</li><li>Ensure comprehensive investigations and implementation of effective corrective and preventive actions.</li></ul> Required Experience & Qualification <ul><li>Bachelor’s degree (Level 7 or higher) in Quality, Engineering, Science, or a related discipline.</li><li>Minimum of 3 years’ proven people management experience.</li><li>5–10 years’ experience in a regulated industry (e.g., medical devices, pharmaceuticals, life sciences).</li><li>Strong working knowledge of Quality Management Systems (QMS), FDA regulations, ISO standards, and NPI processes.</li><li>Demonstrated leadership and people management capability (essential).</li></ul>Additional Notes<ul><li>Responsibilities may evolve based on business needs.</li><li>The Quality Department Manager will communicate any required changes to scope.</li><li>The employee must adhere to all company procedures and GMP requirements at Croom Medical.</li></ul> For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Quality Manager (NPI)

Senior NPI Engineer Overview We are seeking an experienced and driven Senior New Product Introduction (NPI) Engineer to lead the successful launch and integration of new products into an established manufacturing environment. This is a key technical leadership role responsible for ensuring robust product transfer, operational readiness, and continuous improvement within a fast-paced production setting. The ideal candidate will bring strong cross-functional collaboration skills, proven NPI experience, and a passion for driving operational excellence. Key Responsibilities <ul><li>Lead New Product Introduction (NPI) projects from concept through to full production launch, ensuring seamless integration into existing manufacturing processes.</li><li>Provide technical leadership and direction across cross-functional teams to ensure project milestones, quality standards, and timelines are achieved.</li><li>Drive continuous improvement initiatives focused on quality, efficiency, cost reduction, and process optimisation.</li><li>Support the development and execution of engineering strategies aligned with long-term operational and business objectives.</li><li>Collaborate with manufacturing and automation teams to support and implement plant automation initiatives.</li><li>Ensure full compliance with quality, regulatory, and safety standards; participate in audits and continuous system improvements.</li><li>Support capital expenditure planning, including tracking, forecasting, and reporting on project budgets.</li><li>Lead improvements in engineering systems, processes, and procedures to enhance overall site performance.</li><li>Contribute to cost-reduction and “Cost to Win” initiatives, ensuring effective and timely implementation.</li><li>Mentor and support junior engineers, fostering a high-performance, problem-solving team culture.</li></ul> Qualifications & Experience <ul><li>Bachelor’s degree (BSc) in Engineering required; Master’s degree (MSc) desirable.</li><li>Minimum 3–5 years’ engineering experience, including direct involvement in New Product Introduction and product integration within a manufacturing environment.</li><li>Demonstrated experience managing or contributing significantly to complex engineering projects.</li><li>Project Management experience desirable; formal certification advantageous.</li><li>Lean Six Sigma qualification preferred.</li><li>Proven ability to work effectively within cross-functional teams and influence outcomes in high-demand, deadline-driven environments.</li><li>Strong analytical and problem-solving skills with a track record of delivering measurable improvements.</li><li>Excellent communication and stakeholder management skills.</li><li>Adaptable, agile learner with the ability to respond effectively to evolving technologies and business requirements.</li></ul> For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Senior NPI Engineer

We are seeking an experienced and highly motivated Senior Hardware Design Engineer to join a dynamic Engineering & R&D team. This is a senior, hands-on role with a strong focus on hardware architecture and board-level design for next-generation fire and gas detection products, as well as connected IoT systems. This is an exciting opportunity to work across the full product lifecycle, from early concept development and feasibility studies through detailed design, validation, and transition into high-volume manufacturing. You will collaborate closely with firmware, software, validation, and manufacturing teams to deliver robust, compliant, and high-quality safety-critical products. About the Role As a Senior Hardware Engineer, you will play a key role in shaping next-generation products, taking ownership of complex PCB designs and driving the adoption of new technologies. You will be involved in all stages of product development — from architecture definition and schematic design to layout oversight, prototype build, system bring-up, validation, and manufacturing support. This role offers strong visibility of the full product journey, with the opportunity to see your designs successfully manufactured at scale. Key Responsibilities: <ul><li>Define hardware architectures and deliver board-level designs for alarm, sensor, and gateway products</li><li>Lead hardware development from concept through schematic capture, PCB layout support, prototype build, bring-up, and full validation</li><li>Design low-power analogue and mixed-signal circuits including power management, DC-DC converters, battery charging, and battery-powered systems</li><li>Develop processor-based embedded hardware platforms and digital circuit designs using microcontrollers and peripheral interfaces</li><li>Integrate wireless technologies including Zigbee, Z-Wave, WiFi, and Bluetooth, ensuring strong performance and regulatory compliance</li><li>Apply EMC, ESD, and EMI mitigation techniques along with RF desensitisation methods to meet global compliance standards</li><li>Work closely with firmware and software teams on driver development, system integration, and system-level debugging</li><li>Support product certification, regulatory compliance testing, and manufacturing ramp-up activities</li><li>Ensure designs are optimised for DFM and DFT to support cost-effective, high-volume manufacturing</li><li>Produce accurate technical documentation and participate in design reviews</li><li>Provide mentorship and technical guidance to junior engineers where appropriate</li></ul> Essential Requirement:  <ul><li>Honours degree or higher in Electronic Engineering or a related discipline</li><li>Extensive industry experience in hardware design and product development</li><li>Strong experience in low-power circuit design, analogue, and mixed-signal electronics</li><li>Proven experience developing embedded hardware platforms and processor-based systems</li><li>Demonstrated experience with schematic capture and PCB design at board level</li><li>Hands-on experience with interfaces including I2C, UART, SPI, and USB</li><li>Strong understanding of RF fundamentals and wireless system integration</li><li>Proven experience debugging hardware designs across full product lifecycle stages</li></ul> Desirable Skills:  <ul><li>Ability to work independently and make sound engineering decisions</li><li>Strong communication and documentation skills</li><li>Knowledge of manufacturing processes, DFM, and DFT</li><li>Experience working with external manufacturing partners</li></ul> For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Senior Hardware Design Engineer

Senior Test Automation Engineer Location: Shannon, Co. Clare, Ireland Reporting To: Engineering Manager Job Type: Full-Time | Permanent | Onsite About the Role We are seeking a highly skilled and detail-oriented Senior Test Automation Engineer with strong expertise in LabVIEW to join a dynamic R&D environment. This role is ideal for someone passionate about ensuring the highest levels of quality in electronic and IoT-based products. You will play a critical role in validating both hardware and software systems, ensuring products meet rigorous quality, safety, and regulatory standards. Working closely with cross-functional engineering teams, you will contribute directly to delivering robust, reliable, and high-performance products to market. Key Responsibilities <ul><li>Lead the development, analysis, and documentation of test requirements in collaboration with cross-functional stakeholders.</li><li>Own the overall test strategy and detailed planning, ensuring full requirements traceability and risk-based coverage.</li><li>Architect, design, and implement scalable, maintainable automated test systems using NI LabVIEW and TestStand.</li><li>Define comprehensive test specifications, verification methodologies, and acceptance criteria for complex embedded systems.</li><li>Lead complex troubleshooting, debugging, and root-cause analysis activities across hardware and software domains.</li><li>Drive continuous improvement of test frameworks, architecture, and engineering best practices.</li><li>Specify, integrate, and optimize a wide range of measurement instruments and hardware interfaces.</li><li>Ensure compliance with internal quality standards and regulatory requirements; support audits where necessary.</li><li>Mentor and technically guide junior engineers while influencing long-term automation strategy.</li></ul>Essential Qualifications & Skills <ul><li>Minimum 5 years’ experience in automated test development for embedded electronic products.</li><li>Strong proficiency in NI LabVIEW (Certified LabVIEW Developer (CLD) or higher certification highly desirable).</li><li>Solid understanding of embedded systems, electronics, and measurement instrumentation.</li><li>Experience with hardware/software interfacing protocols such as Serial, I&sup2;C, SPI, and CAN.</li><li>Strong analytical, problem-solving, and documentation skills.</li><li>Excellent communication skills and ability to collaborate effectively across multidisciplinary teams.</li></ul>Desirable / Advantageous Skills <ul><li>Familiarity with automated QA tools (e.g., Selenium, Python, CLI-based tools).</li><li>Degree in Electronic Engineering or a related discipline.</li><li>Experience with TestStand, DAQ systems, or instrument control.</li><li>Comfortable working with mains-powered products.</li><li>Experience with defect tracking tools (e.g., Jira).</li><li>Proficiency with source control systems (e.g., GitHub, Bitbucket, SourceTree).</li></ul>

Senior Test Automation Engineer

About the job Our client, a leading manufacturing organisation is seeking a Senior Treasury Analyst to join their team in Shannon. This is an exciting opportunity to play a key role in managing treasury operations, investment activities and risk management while contributing to decision-making that drives the Group’s success. Responsibilities: Treasury Management: <ul><li>Assist in managing liquidity, cash flow, and banking relationships.</li><li>Monitor and assist in forecasting cash requirements and operational funding needs.</li><li>Execute treasury transactions, including money market and foreign exchange activities.</li></ul> Investment Analysis & Reporting <ul><li>Prepare comprehensive liquidity and investment analysis and reporting.</li><li>Analyse financial data and trends to support decision-making processes.</li><li>Develop and maintain financial models for forecasting and budgeting.</li><li>Prepare regular and ad-hoc reports on treasury and investment activities.</li></ul> Risk Management & Compliance <ul><li>Identify and assess financial risks related to treasury and investment activities. • Monitor risk exposures against agreed limits and ensure ongoing compliance.</li><li>Implement agreed risk mitigation strategies and ensure compliance with company policies and regulatory requirements.</li><li>Support the continued development and implementation of appropriate policies, including in relation to liquidity, counterparties, concentration, interest rate risk and FX risks.</li><li>Support and contribute to best practice treasury control environment.</li><li>Lead on KYC and other relevant compliance processes.</li></ul> Skills and Experience: <ul><li>Honours degree in Finance, Accounting, Economics, or related field.</li><li>Professional qualification (e.g., Accounting, Corporate Treasury) is an advantage or the willingness to pursue one.</li><li>3–5 years’ experience in treasury, investment management or financial analysis.</li><li>Proven experience in data analysis, financial modelling and treasury systems.</li><li>Strong knowledge of financial instruments, markets and risk management.</li></ul> Why apply for this job: <ul><li>Competitive compensation package</li><li>Comprehensive benefits coverage</li><li>Hybrid work arrangement — 4 days in the office, 1 day working from home</li></ul> For a confidential conversation about the role contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Senior Treasury Analyst

Manufacturing Project Engineer (12-Month Contract) Location: County Cork, Ireland Company Overview: A leading global medical device company based in County Cork is seeking a Manufacturing Project Engineer on a 12-month contract. The role will focus on supporting regulatory compliance, validation, change control, and project execution in a fast-paced manufacturing environment. Key Responsibilities: <ul><li>Regulatory Compliance: Ensure adherence to medical device regulations (ISO 13485, FDA, MDR) in manufacturing processes.</li><li>Validation: Lead and execute validation activities (IQ/OQ/PQ) for equipment, processes, and systems.</li><li>Change Control: Oversee and support change control processes, ensuring proper documentation and approval.</li><li>Project Execution: Assist in managing project tasks, timelines, and deliverables, working with cross-functional teams.</li><li>Documentation: Maintain clear documentation for validation, change control, and project progress.</li></ul>Required Skills and Experience: <ul><li>3 years of experience in medical device manufacturing, including regulatory compliance and validation.</li><li>Strong knowledge of FDA, ISO 13485, and EU MDR regulations.</li><li>Experience in change control processes and project task execution.</li><li>Excellent attention to detail, communication, and problem-solving skills.</li><li>Ability to work in a cross-functional team and manage multiple priorities.</li></ul>Contract Duration: 12 months, with potential for extension. Application Process: Please submit your CV and cover letter outlining relevant experience.

Manufacturing Project Engineer

Senior Front-End Engineer (Vue.js / TypeScript / Canvas) Contract – 6 Months (Strong Extension Potential) Remote – EU (Ireland a bonus) We’re looking for a Senior Front-End Engineer to take a leading hands-on role in delivering a newly redesigned internal platform. This is a high-impact position focused on translating high-quality UX/UI designs into robust, scalable, and maintainable front-end solutions. You’ll be working on complex, interactive interfaces; including rich canvas-based functionality and helping shape front-end architecture, standards, and testing strategy. This role suits someone who enjoys solving challenging UI problems, owning implementation end-to-end, and collaborating closely with design and back-end teams. Responsibilities: <ul><li>Implement pixel-perfect, accessible user interfaces using Vue.js and TypeScript</li><li>Build and maintain complex, interactive components using HTML5 Canvas</li><li>Work with canvas libraries such as Fabric.js to manage rendering and interactions</li><li>Translate design system and Figma outputs into scalable, reusable component architecture</li><li>Collaborate with Product and Design to interpret, refine, and improve UX decisions</li><li>Integrate front-end features with back-end APIs and data flows</li><li>Write clean, well-structured, maintainable code</li><li>Practice test-driven development (TDD) where appropriate</li><li>Develop and maintain automated tests, including end-to-end tests using Playwright</li><li>Improve performance, reliability, and overall developer experience</li><li>Help define and uphold front-end standards and best practices</li><li>Contribute ideas to enhance usability and efficiency beyond the initial redesign</li></ul> Requirements/Experience: <ul><li>Strong experience as a Senior Front-End Engineer</li><li>Deep hands-on expertise in Vue.js</li><li>Strong production experience with TypeScript</li><li>Significant experience building complex UI interactions using HTML5 Canvas</li><li>Experience with Fabric.js (or similar canvas libraries)</li><li>Solid understanding of modern JavaScript (ES6 ), HTML, and CSS</li><li>Proven experience writing automated tests, including end-to-end testing with Playwright</li><li>Demonstrated commitment to clean code, maintainable architecture, and sound engineering principles</li><li>Experience working from design systems and Figma (or similar tools)</li><li>Comfortable working autonomously in a contract environment</li><li>Strong test and automation mindset</li></ul> Nice to Have <ul><li>Experience implementing layered visual systems (overlays, z-ordering, toggling)</li><li>Familiarity with tile servers and tile-based rendering concepts</li><li>Experience with PrimeVue or similar Vue component libraries</li><li>Broader front-end testing experience (unit, integration, visual regression)</li><li>Experience building internal tools or complex data-heavy applications</li><li>Exposure to healthcare or other regulated environments</li></ul> For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Senior Frontend Developer

Head of Engineering – R&D Role Overview Lead and scale a multidisciplinary engineering team (hardware, embedded software, mechanical) delivering next-generation products from concept through mass production. This role drives technical excellence, organizational growth, and close collaboration with manufacturing to ensure high-quality, on-time delivery aligned with strategic goals. Key Responsibilities Leadership & Organization <ul><li>Lead, mentor, and grow engineering managers and teams.</li><li>Build a high-performance culture and scalable team structure.</li><li>Plan headcount and capability development aligned with growth.</li></ul>Product & Technical Oversight <ul><li>Own end-to-end product development and system integration.</li><li>Ensure strong engineering rigor, validation, DFM/DFT, and risk management.</li><li>Provide technical leadership across projects and support sustaining engineering.</li></ul>Delivery & Execution <ul><li>Oversee multiple concurrent projects, ensuring on-time, on-budget delivery.</li><li>Drive structured design reviews, testing, and qualification processes.</li></ul>Process & Performance <ul><li>Establish scalable engineering processes and KPIs.</li><li>Implement continuous improvement practices.</li></ul>Budget & Strategy <ul><li>Manage engineering budgets and resources.</li><li>Contribute to long-term product and technology roadmap.</li></ul>Candidate Profile <ul><li>Bachelor’s degree in Engineering or related field.</li><li>8 years in product development, including 5 years leading teams of 30 .</li><li>Proven track record delivering complex hardware/software products to market.</li><li>Experience in electronics or high-volume manufacturing preferred.</li><li>Strong leadership, project management, and cross-functional collaboration skills.</li></ul>Work Environment Full-time, on-site with manufacturing. Regular UK travel. Fast-paced, hands-on environment.   For a confidential conversation about the role contact Tommy on 353 86 2044918 or tmckeown@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Head of Engineering - R&D

About the job Talent Acquisition Specialist Location: Sligo, Westport or Cork Contract: 23-Month Fixed-Term Contract Overview An exciting opportunity has arisen for an experienced Talent Acquisition Specialist to join a fast-paced environment on a 23-month contract. This role will focus on delivering high-quality, in-house recruitment support, partnering closely with hiring managers to attract and secure top talent while driving strong recruitment outcomes. Key Responsibilities <ul><li>Lead recruitment activity for a designated team/function and other areas as assigned.</li><li>Manage the full recruitment lifecycle from sourcing through to offer stage.</li><li>Attract top talent and develop a strong pipeline of qualified candidates for current and future hiring needs.</li><li>Conduct candidate pre-screening and assessments.</li><li>Partner with hiring managers to develop and execute proactive sourcing strategies aligned to business priorities.</li><li>Develop and manage talent pools for critical and future skill requirements.</li><li>Manage open job requisitions and maintain accurate records within SmartRecruiters.</li><li>Track and report recruitment metrics and key accomplishments.</li><li>Provide market intelligence including industry insights, talent trends, and compensation benchmarking.</li><li>Prepare and approve competitive offer packages, including market data research.</li><li>Ensure compliance with employment legislation and company policies related to applicant tracking and reporting.</li><li>Build strong business partnerships with hiring managers and leadership on all staffing-related initiatives.</li></ul> Requirements <ul><li>2–3 years’ recruitment experience in a fast-paced, competitive environment.</li><li>Pharmaceutical or healthcare recruitment experience strongly preferred.</li><li>In-house recruitment experience is essential.</li><li>Proven experience in proactive sourcing and talent pipeline development.</li><li>Strong business presence with the ability to build credibility and deliver results.</li><li>Experience managing requisitions within SmartRecruiters preferred.</li></ul> For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

TA Specialist

About the job Act as the Site Electrical Subject Matter Expert (SME) to develop, implement, and manage a structured Preventative and Predictive Electrical Maintenance Program. Ensure site-wide electrical infrastructure is compliant with European standards and ETCI regulations while maintaining asset integrity within the CMMS system. Key Responsibilities: <ul><li>Identify and document all HV, MV, and LV electrical systems across site.</li><li>Develop and maintain electrical asset hierarchies and A-CAD drawings from incomer to final distribution boards.</li><li>Implement structured PM programs for all electrical panels, switchgear, and infrastructure.</li><li>Establish and maintain life support systems hierarchy (Emergency Lighting, Fire Alarm, Gas Detection, LEL systems).</li><li>Populate and maintain all electrical assets and job plans within CMMS.</li><li>Develop, implement, and maintain an Electrical Maintenance SOP.</li><li>Maintain Arc Flash studies, short circuit studies, signage, and PPE requirements.</li><li>Develop and maintain ATEX register, ATEX PM program, and inspection regime for ATEX PPE and tools.</li><li>Manage site electrical shutdowns (power down/up) ensuring safety, GMP, and minimal operational disruption.</li><li>Own electrical change control and stakeholder coordination.</li><li>Maintain as-built drawings and electrical handover documentation.</li><li>Represent electrical function during audits and inspections.</li><li>Provide condition reports and ensure compliance for critical systems including:</li><li>MV/LV switchgear and transformers</li><li>Generators and UPS systems</li><li>Power quality, harmonic filters, and PFC systems</li><li>Lighting and emergency systems</li><li>Lightning and surge protection</li><li>MCCs, switch rooms, cabinets</li><li>Thermographic surveys and PAT testing</li><li>Drive continuous improvement and infrastructure upgrades.</li><li>Act as electrical lead for site projects and provide design, risk, and value engineering input.</li></ul> Qualifications: <ul><li>Bachelor’s Degree in Electrical or Mechatronic Engineering OR National Craft Certificate in Electrical Engineering with Management qualification</li></ul> Experience: <ul><li>10 years industrial electrical experience.</li><li>Strong knowledge of European electrical standards, ETCI regulations, ATEX, Arc Flash, and industrial power systems.</li><li>Experience implementing CMMS-based maintenance programs.</li></ul> For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Electrical Engineer

Product Quality Engineer Role Overview The Product Quality Engineer acts as the key link between Quality and R&D, ensuring hardware and software designs meet quality, reliability, and regulatory standards from concept through production and sustaining phases. The role supports Production, Test, Process Quality, Purchasing, and R&D in resolving product-related issues, particularly those involving hardware and firmware functionality. Key Responsibilities<ul><li>Review product designs, schematics, PCB layouts, and hardware specifications to identify quality and reliability risks.</li><li>Lead design risk assessments (e.g., DFMEA) and support root cause investigations.</li><li>Support NPI validation and verification activities.</li><li>Assist with new vendor and component approval processes.</li><li>Analyse test data and support hardware/software testing from a quality perspective.</li><li>Provide technical support to Production and Test teams on product-related issues.</li><li>Ensure traceability and compliance with relevant standards.</li><li>Participate in design reviews and support audits related to design controls.</li></ul>Qualifications & Skills<ul><li>Degree in Electronic, Electrical, Software Engineering, or related discipline.</li><li>5 years’ experience in a Quality or R&D role within a regulated industry.</li><li>Strong understanding of product lifecycle and design controls.</li><li>Ability to read electronic schematics and interpret technical drawings.</li><li>Experience with FMEA, risk management, and root cause analysis.</li><li>Knowledge of embedded systems, firmware, or hardware/software integration.</li><li>Strong cross-functional communication skills.</li></ul>

Product Quality Engineer

Job Title: Production Operator Job Summary: Work as part of a production/operations team, ensuring equipment, work areas, and materials are prepared and operations run safely and efficiently, in line with regulatory and organizational standards. Shift Flexibility: <ul><li>Day: Mon–Fri, 08:00–16:30 (Fri finish 15:30), 39 hours/week</li><li>Evening: 16:00–00:00 (Fri finish 23:00), 16.7% shift allowance</li><li>Night: 00:00–08:00 (Fri finish 07:00), 27% shift allowance</li></ul> Key Responsibilities: <ul><li>Prepare and operate moulding, automated assembly, pad printing, and manual assembly equipment</li><li>Troubleshoot day-to-day manufacturing issues affecting safety, quality, or efficiency</li><li>Conduct quality checks and achieve production targets</li><li>Supply materials safely and on time; label and pack components and finished products</li><li>Operate advanced metrology equipment and robotic/vision systems</li><li>Participate in new product introductions, improvement projects, and continuous improvement initiatives</li><li>Document activities according to GMP standards</li><li>Cross-train team members and assist in onboarding new staff</li><li>Perform manual assembly and visual inspections as needed</li></ul> Essential Qualifications & Skills: <ul><li>Leaving Certificate or equivalent, or relevant work experience</li><li>Minimum 1 year experience in a regulated manufacturing environment</li><li>Basic knowledge of Microsoft Office</li></ul>Desirable: <ul><li>3rd level education</li></ul> For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose.

Production Operator

Senior Quality Engineer – 12 month Fixed Term contract  Job Summary: We are seeking a proactive and detail-oriented Quality Compliance Engineer to join our Quality Assurance team for a 12 month contact. This role is a critical technical position responsible for ensuring that all medical device manufacturing activities meet the latest global regulatory requirements, including ISO 13485:2016 and the fully implemented EU MDR.   Your responsibilities will include completion of end-to-end validation lifecycle (IQ/OQ/PQ), performing rigorous risk assessments (pFMEAs), and supporting the change control process to maintain product integrity.  In addition, you will be a primary Quality Liaison for the production floor, supporting and driving root cause investigations and ensuring that manufacturing processes are stable, compliant, and ready for regulatory inspection. Key Responsibilities: <ul><li>Product and Process Validation: Develop, review, and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment and processes to ensure high-degree assurance of product requirements.</li></ul><ul><li>Risk Management: Lead and maintain risk management files, including pFMEAs  ensuring that all potential failure modes are identified and mitigated.</li><li>Production Quality Support: Provide real-time QA support to the operations team to address non-conformances, perform root cause analysis, and implement effective CAPAs (Corrective and Preventive Actions).</li><li>Audit Readiness: Support internal and external audits by maintaining accurate documentation and ensuring all plant personnel follow cGMP requirements.</li><li>Statistical Analysis: Apply statistical techniques and tools (e.g., Minitab) to analyze process data, identify trends, and support data-driven decision-making for process improvements.</li><li>Other duties as assigned</li></ul>Qualifications: Required: <ul><li>Bachelor’s degree in Engineering (Biomedical, Mechanical, Electrical, or related field) or Life Sciences.</li><li>5 years of experience in quality assurance or Validation in the medical device or a similarly regulated industry.</li><li>Solid understanding of ISO 13485, EU MDR, ISO 14971 and relevant medical device regulations.</li><li>Strong analytical and problem-solving skills; experience with root cause analysis tools (e.g., 5 Whys, Fishbone, FMEA).</li><li>Excellent written and verbal communication skills, especially in technical writing and documentation.</li><li>Proficient in data analysis tools such as Excel, Minitab, Power BI or similar.</li></ul>Preferred: <ul><li>Certified Quality Engineer (ASQ CQE) or similar professional certification.</li><li>Certified Internal or Lead Auditor</li><li>Knowledge of EU MDR and international medical device regulations.</li><li>Six Sigma or Lean Certification is a plus.</li></ul>Competencies: <ul><li>Strong attention to detail and commitment to quality.</li><li>Ability to manage multiple tasks and projects in a fast-paced environment.</li><li>Collaborative mindset with ability to work effectively across departments.</li><li>Self-motivated with a continuous improvement mindset.</li></ul>

Senior Quality Engineer

Senior R&D Engineer I Location: Mayo Department: Research & Development Role Overview The successful candidate will lead or support projects within the Core Business Initiatives (CBI) team, focusing on existing hydrophilic coated products and technologies. This role will also contribute to the development and integration of new materials, processes, and technologies into both new and existing products and manufacturing processes. The position requires a strong understanding of medical device design controls and the ability to work effectively within cross-functional teams, collaborating with colleagues at all organizational levels to deliver high-quality, customer-focused solutions. Key Responsibilities <ul><li>Provide technical support to New Product Development (NPD), Global Marketing, Engineering, and Manufacturing teams</li><li>Lead or support project teams in evaluating and demonstrating the feasibility of alternative materials, processes, or technologies for new and existing products</li><li>Prepare technical documentation in line with regulatory requirements, design controls, and internal development processes</li><li>Collaborate with cross-functional stakeholders to gather requirements and ensure proposed technical solutions meet business and customer needs</li><li>Develop experimental protocols and test plans, and manage product builds, transportation, storage, and testing activities</li><li>Conduct statistical analysis of test data and prepare detailed technical reports outlining results, conclusions, and recommendations</li><li>Represent the R&D function on cross-functional teams throughout the New Product Commercialization process</li></ul> Experience Requirements <ul><li>Minimum of 5 years’ experience in a technical role, ideally within Research & Development or Process Development</li><li>Experience with materials and coatings is required; knowledge of hydrophilic coatings and their application to various material substrates would be a strong advantage</li></ul> Educational Requirements <ul><li>Honours Bachelor’s or Master’s degree in one of the following disciplines:</li><li>Materials Science</li><li>Polymer Science or Engineering (Polymer or Biomedical)</li><li>Biochemical Engineering</li><li>Or a related engineering/scientific field</li></ul> Skills & Technical Knowledge <ul><li>Knowledge of hydrophilic coating technologies, materials science, and surface chemistry</li><li>Strong initiative with the ability to execute project responsibilities, overcome obstacles, and manage multiple priorities</li><li>Good understanding of medical device design controls and associated documentation</li><li>Proven experience working effectively as part of cross-functional technical teams</li><li>Strong problem-solving, decision-making, and root cause analysis skills</li><li>Ability to clearly communicate technical concepts and ideas to a wide range of stakeholders</li><li>Understanding of manufacturing processes, mechanisms, materials, tolerance analysis, and design for manufacturing</li></ul>

Senior R&D Engineer

Job Title:     Principal Scientist Location:    Mayo Status:     Permanent Position Summary: <ul><li>We are looking for a skilled Principal Scientist with deep expertise in polymers to join the team.</li><li>You will conduct high-level analysis of data, interprets results, communicates findings, supports the successful completion of global projects, supports the technical component of product development and drives innovation</li></ul>  Key Responsibilities: <ul><li>Lead the identification/sourcing, design, development, and optimisation of polymeric formulations</li><li>Provide technical leadership in the selection and development of polymer materials, technology, equipment and processes</li><li>Develop and execute experimental plans, including formulation testing, stability studies, and material performance evaluations.</li></ul> Qualifications and Requirements: <ul><li>Extensive experience in Polymer R&D and Manufacturing</li><li>PhD in Polymer Science, Materials Science, Chemical Engineering</li><li>Competent in the principles and practices of polymer formulations, adhesives and associated chemistry.</li><li>Materials science background with hands-on experience with sourcing, optimising and developing materials</li></ul>For a confidential conversation about the position contact Karl on 353 86 201 1223 or klippett@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Principal Scientist

Job Title: CQV Lead Engineer Location: Athenry, Ireland Contract: 3 Month Fixed Term Job & Company Overview: Our client is a global leader in Medical Device Manufacturing working to transform how people manage their health. They are seeking a highly motivated and skilled CQV Lead Engineer to support the setup and validation of their new Greenfield manufacturing facility in Athenry. This is a 3-month contract role that will play a critical part in ensuring the successful construction, commissioning, and qualification of all facility, utility, and equipment systems. This position involves two key phases: <ol><li>Construction & Commissioning Oversight – Managing and coordinating Construction Complete, Turnover, and Mechanical Completion through Commissioning in collaboration with the General Contractor (GC).</li><li>Qualification Execution – Generating, executing, and approving Qualification documents for Direct Impact Systems (Facility, Utility, and Equipment).</li></ol> Key Responsibilities: <ul><li>Lead and coordinate Construction Completion, Turnover, and Mechanical Completion activities.</li><li>Oversee commissioning of all systems with the General Contractor (GC).</li><li>Develop, execute, and approve IQ, OQ, PQ qualification protocols for direct impact systems.</li><li>Work closely with cross-functional teams, including Engineering, Quality, and Operations, to ensure compliance with regulatory requirements.</li><li>Identify and resolve commissioning and qualification challenges to maintain project timelines.</li><li>Ensure adherence to GMP, FDA, ISO 13485, and other relevant regulations.</li><li>Maintain detailed documentation of all CQV activities.</li></ul> Requirements: <ul><li>Proven experience in CQV (Commissioning, Qualification, and Validation) within Medical Device or Pharmaceutical industries.</li><li>Strong track record in large-scale campus delivery of greenfield projects.</li><li>Expertise in Facility, Utility, and Equipment Qualification.</li><li>Knowledge of cGMP, FDA, ISO 13485, and industry best practices.</li><li>Strong project management and stakeholder coordination skills.</li><li>Ability to problem-solve and drive tasks to completion in a fast-paced environment.</li></ul> For a confidential conversation about the role please apply for the role or contact Gerard Cunniffe at gcunniffe@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose.

CQV Engineer

Job Title: Senior Robotics Engineer Location: Dundalk Salary: €75000 - depending on exp. Our client are seeking an experienced Senior Robotics Engineer to support the delivery of complex automation and robotics solutions within regulated manufacturing environments. This is a senior, hands-on role focused on the design, integration, commissioning, and optimisation of robotic systems, working closely with multi-disciplinary engineering teams to deliver high-quality, compliant automation solutions. The successful candidate will bring strong technical expertise in industrial robotics and controls, with the ability to lead technical delivery, mentor junior engineers, and contribute to project execution from concept through to handover. Key Responsibilities: <ul><li>Lead the design, development, and implementation of robotic automation solutions for manufacturing environments.</li><li>Program, configure, and commission industrial robots (e.g. Fanuc, ABB, KUKA, Yaskawa or similar).</li><li>Develop and support robot safety systems, including risk assessments and compliance with applicable standards.</li><li>Integrate robotics with PLC, HMI, vision systems, conveyors, and peripheral equipment.</li><li>Support FAT, SAT, and on-site commissioning, including technical documentation and troubleshooting.</li><li>Provide technical leadership across projects, supporting planning, estimation, and delivery activities.</li><li>Troubleshoot and resolve complex robotics and automation issues during build and operational phases.</li></ul> Skills & Experience: <ul><li>Degree in Automation, Mechatronics, Electrical, Mechanical Engineering, or a related discipline.</li><li>Significant experience as a Robotics Engineer in industrial or regulated manufacturing environments.</li><li>Hands-on experience programming and commissioning industrial robotic platforms.</li><li>Strong understanding of PLC-based control systems, industrial networks, and automation architectures.</li><li>Experience integrating robotics into automated production lines and complex machinery.</li><li>Knowledge of robot safety standards, risk assessments, and functional safety principles.</li><li>Exposure to pharma, biotech, medical device, or food & beverage environments is advantageous.</li><li>Familiarity with GMP, ISO, or other regulated manufacturing standards.</li><li>Experience with vision systems, motion control, and advanced automation technologies is beneficial.</li></ul> For a confidential conversation about the role please apply for the role or contact Gerard Cunniffe at gcunniffe@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose.

Senior Robotics Engineer

Digital Transformation Project Manager The Digital Transformation Project Manager is a pivotal leader driving the our clients site’s journey toward Factory 4.0. This role is responsible for coordinating a portfolio of digital transformation initiatives that enhance operational efficiency, optimise manufacturing processes and support the organisation’s commitment to innovation and operational excellence. The ideal candidate will bring a strong understanding of digital technologies, project and portfolio management, and regulated manufacturing environments, ideally within biopharmaceutical or advanced manufacturing settings. Key Responsibilities: <ul><li>Coordinate a portfolio of digital transformation projects, liaising with above-site teams and SMEs to represent the Westport site.</li><li>Collaborate with site leadership to develop and implement digital strategies aligned with operational and business objectives.</li><li>Work cross-functionally with IT, Operations, Regulatory Affairs and Quality to gather requirements and ensure alignment on project goals.</li><li>Drive value analysis and business case development for both new and existing digitalisation initiatives.</li><li>Own and/or support financial long-range planning and capital acquisition processes.</li><li>Communicate project status, risks, milestones and benefits to stakeholders at all levels.</li><li>Develop and implement effective change management strategies to ensure strong user engagement and adoption.</li><li>Represent the business/site in the deployment of digital tools and technologies, contributing to system architecture and configuration discussions as the operational voice.</li><li>Lead cross-functional project teams to deliver projects on time, within scope and with strong stakeholder engagement.</li><li>Define, track, and monitor KPIs to measure the success and sustainability of digital initiatives.</li><li>Ensure all initiatives comply with relevant regulatory requirements and internal quality standards.</li></ul> Qualifications: <ul><li>Bachelor’s degree in Business Administration, Information Technology, Engineering, or a related discipline.</li><li>Proven experience in digital transformation and project management, preferably in manufacturing or biopharmaceutical environments.</li><li>Experience with financial planning, budgeting, and business case development.</li><li>Exposure to Lean, Six Sigma, or other process improvement methodologies.</li><li>Strong interest in or knowledge of digitalisation and operational excellence (e.g. IoT, AI, robotics, Industry 4.0).</li><li>Excellent project and portfolio management skills, with the ability to manage multiple initiatives and cross-functional resources.</li><li>Strong communication, analytical, and problem-solving skills, with the ability to influence stakeholders at all levels.</li></ul> Preferred Qualifications: <ul><li>Master’s degree in a relevant field.</li><li>Certifications such as Lean Six Sigma Green/Black Belt, PMP, or Industry 4.0–related credentials.</li><li>Experience delivering Industry 4.0 or digital manufacturing projects in regulated environments.</li></ul> For a confidential conversation about the role please apply for the role or contact Gerard Cunniffe at gcunniffe@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose.

Digital Transformation Project Manager

Job Title:    Senior Packaging Engineer Location:    Mayo Status:      Permanent Position Summary: <ul><li>Seeking a Senior Packaging Engineer to join their Global Packaging team, where your work will directly impact patient care worldwide.</li><li>In this role, you’ll drive packaging solutions for their products, shaping packaging strategies from concept to commercialization.</li><li>You’ll collaborate across teams, influence critical decisions and ensure our products meet the highest standards of safety, performance, and innovation.</li></ul>  Key Responsibilities: <ul><li>Design, develop, and validate sterile and non-sterile packaging systems</li><li>Drive continuous improvement and cost-saving initiatives</li><li>Lead and own packaging projects for new product development and improvements to existing products</li><li>Ensure compliance with global regulations while representing Hollister at industry events</li></ul> Qualifications and Requirements: <ul><li>Deep knowledge of ISO 11607, ASTM, ISTA and EU MDR/FDA guidance</li><li>Strong technical writing, validation and statistical analysis skills</li><li>Packaging experience in medical devices or related industries</li></ul>  For a confidential conversation about the position contact Karl on 353 86 201 1223 or klippett@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Senior Packaging Engineer

Senior Quality Engineer Location: Galway, Ireland About the Role We are looking for an experienced Senior Quality Engineer to join our team in Galway. This role is key to ensuring product and process quality for medical devices in compliance with global regulatory standards. Key Responsibilities <ul><li>Support new product introductions (NPI) and existing manufacturing operations.</li><li>Lead non-conformance, CAPA, and complaint investigations.</li><li>Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and MDR.</li><li>Collaborate with cross-functional teams on design controls, risk management, and validation.</li><li>Support internal and external audits and drive continuous improvement.</li><li>Manage supplier quality and mentor junior team members.</li></ul>Qualifications <ul><li>Degree in Engineering, Science, or related field.</li><li>5 years’ experience in quality within a medical device or regulated industry.</li><li>Strong knowledge of regulatory standards, CAPA, and validation.</li><li>Experience with Lean/Six Sigma tools; CQE or Green Belt a plus.</li><li>Excellent problem-solving and communication skills.</li></ul>

Design Assurance Manager – Galway Role Summary The Design Assurance Manager is responsible for ensuring medical devices are designed and developed in compliance with applicable regulatory requirements and quality standards. This role provides leadership across design controls, risk management, and verification and validation activities throughout the product lifecycle, while partnering closely with cross-functional teams. Key Responsibilities <ul><li>Own and maintain design control processes in compliance with ISO 13485, EU MDR, and FDA 21 CFR 820.</li><li>Ensure complete and compliant Design History Files (DHF) and design documentation.</li><li>Lead risk management activities in accordance with ISO 14971.</li><li>Oversee design verification and validation, including usability engineering where applicable.</li><li>Support design transfer to manufacturing and related validation activities.</li><li>Provide design assurance input to design changes, CAPAs, complaints, and post-market activities.</li><li>Support regulatory submissions and audits (Notified Body, FDA, internal).</li></ul>Qualifications & Experience <ul><li>Bachelor’s degree in Engineering, Science, or related field.</li><li>5 years experience in design assurance, quality, or regulatory roles within the medical device industry.</li><li>Strong working knowledge of ISO 13485, ISO 14971, EU MDR, and FDA design controls.</li><li>Experience supporting audits and regulatory submissions.</li></ul>Key Skills <ul><li>Strong attention to detail and documentation skills</li><li>Effective cross-functional communication</li><li>Risk-based decision making</li><li>Ability to work independently in a regulated environment</li></ul>

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WHAT WE BUILD ON<h2>At Sterling, we are driven by our values.</h2>For more than five decades, our commitment to quality has been the cornerstone of our success. We always act with integrity&mdash;taking responsibility for our work, caring for our people, and staying focused on safety and sustainability. Respect for people is at the heart of our business&mdash;clients and employees alike. We have an unrelenting focus on inclusion - we are a diverse, well-rounded team of thinkers and doers that embrace all perspectives. A diverse, well-rounded team of thinkers and doers helps Sterling embrace all perspectives. This culminates in a positive impact on the work we do.

<h5 style="text-align: center;">Since 1969, Sterling has been focused on cultivating relationships and&nbsp;is in the business of building trust.</h5>

INVESTED IN YOUR SUCCESS<h2>What we do is more than a job.</h2>At Sterling, we work every day to create solutions to our clients&rsquo; business challenges while advancing our employees&rsquo; career objectives. We support your team in everything we do, from cutting-edge process development to hiring for your next success. Sterling drives expected outcomes while ensuring safety and compliance within your most complex projects.

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<h2>PROUD TO BE WOMAN-OWNED.</h2><div class="flex-shrink-0 flex flex-col relative items-end"><div><div class="pt-0"><div class="gizmo-bot-avatar flex h-8 w-8 items-center justify-center overflow-hidden rounded-full"><div class="relative p-1 rounded-sm flex items-center justify-center bg-token-main-surface-primary text-token-text-primary h-8 w-8">&nbsp;</div></div></div></div></div><div class="group/conversation-turn relative flex w-full min-w-0 flex-col agent-turn"><div class="flex-col gap-1 md:gap-3"><div class="flex max-w-full flex-col flex-grow"><div class="min-h-8 text-message flex w-full flex-col items-end gap-2 whitespace-normal break-words [.text-message+&amp;]:mt-5" dir="auto" data-message-author-role="assistant" data-message-id="497c14f8-4331-4cd4-a0a0-847f5c2bf610" data-message-model-slug="gpt-4o"><div class="flex w-full flex-col gap-1 empty:hidden first:pt-[3px]"><div class="markdown prose w-full break-words dark:prose-invert light">We're excited to announce that Sterling Engineering Limited has officially met the qualifications to be named a Certified Women&rsquo;s Business Enterprise by WeConnect International!This certification reflects our commitment to diversity, leadership and excellence, reinforcing our dedication to empowering women in business. We&rsquo;re proud to continue building strong partnerships and delivering top-quality engineering and staffing solutions with this recognition.<img src="https://cdn.sourceflow.co.uk/yi17tb2pmbvmyho8k83htie7aurb" alt="" width="400" height="179">&nbsp;</div></div></div></div></div></div>

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<h2>Professional Services</h2><h6>Take your projects from planning to reality.</h6>Every project has a range of challenges that need to be met. If your organization seeks expertise to identify and implement these solutions, you&rsquo;re looking for Sterling Engineering. With decades of experience and a wide range of knowledge, we analyze problems and design solutions.

<h2>Engineering Services</h2><h6>Take your projects from planning to reality.</h6>Every project has a range of challenges that need to be met. If your organization seeks expertise to identify and implement these solutions, you&rsquo;re looking for Sterling Engineering. With decades of experience and a wide range of knowledge, we analyze problems and design solutions.

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Every project has a range of challenges that need to be met. If your organization seeks expertise to identify and implement these solutions, you&rsquo;re looking for Sterling Engineering. With decades of experience and a wide range of knowledge, we analyze problems and design solutions.

<h2>Professional Services</h2>&nbsp;<h6>Take your projects from planning to reality.</h6>Every project has a range of challenges that need to be met. If your organization seeks expertise to identify and implement these solutions, you&rsquo;re looking for Sterling Engineering. With decades of experience and a wide range of knowledge, we analyze problems and design solutions.

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<h5>ENGINEERING SERVICES</h5>Sterling&rsquo;s experienced engineers can guide you from concept to prototype production or testing to manufacturing. With experience in multiple industries, we can deliver a creative approach to the project, accelerating time to market.Our experienced, multi-disciplined team of Project Managers, Engineers and Designers, led by licensed Professional Engineers (PE), provide Project Management, Engineering, Design, Commissioning, Qualification, and Validation (CQV) to Manufacturing, OEM, and R&amp;D customers.&nbsp;<h5>PROFESSIONAL SERVICES</h5>Our recruiters are experts in their related industries and talent skill sets. We leverage our industry relationships built since 1969, propriety database, and invested resources to connect you with the best engineering and technical talent.<ul><li>Recruiting structure driven by industry disciplines</li><li>We fully prescreen &amp; qualify candidates before submittal</li><li>90%+ of our business is from repeat clients</li></ul>

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Our recruiters are experts in their related industries and talent skill sets. We leverage our industry relationships built since 1969, propriety database, and invested resources to connect you with the best engineering and technical talent.&nbsp;<ul><li style="font-weight: bold;">Recruiting structure driven by industry disciplines</li><li style="font-weight: bold;">We fully prescreen &amp; qualify candidates before submittal</li><li style="font-weight: bold;">90%+ of our business is from repeat clients</li><li style="font-weight: bold;">2022 Manage HR Top Contingent Workforce Services Company</li><li>Best of Staffing Awards <ul><li>Client Satisfaction &ndash; 11 Consecutive Years  Talent Satisfaction &ndash; 10 Consecutive Years  Employee Satisfaction &ndash; 4 Consecutive Years</li></ul></li></ul>

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<h2>Service Summary</h2>Elevate your product development journey with our cutting-edge Product Engineering services. We specialize in guiding your product through every stage of development. Our focus on scalability and future-proofing anticipates growth and technological advancements, providing a solid foundation for sustained success. Choose our Product Engineering services for a strategic partnership that goes beyond development &ndash; it&rsquo;s about shaping the future of your product portfolio with innovation, efficiency, and quality at its core.<table style="border-collapse: collapse; width: 100.17%; height: 35px;" border="1"><colgroup><col style="width: 49.8305%;"><col style="width: 49.8305%;"></colgroup><tbody><tr style="height: 17.5px;"><td style="height: 17.5px;">Concepting</td><td style="height: 17.5px;">Detailing</td></tr><tr style="height: 17.5px;"><td style="height: 17.5px;">Product development</td><td style="height: 17.5px;">Reverse engineering</td></tr><tr><td>Simulation</td><td>Materials selection</td></tr><tr><td>Design for manufacturability</td><td>Prototyping</td></tr><tr><td>&nbsp;</td><td>&nbsp;</td></tr></tbody></table>

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Let&rsquo;s engineer a solution together.&nbsp;

<h1>Life Sciences Staffing Solutions</h1>

<h3>Did you know Sterling also provides outsourced design and engineering solutions for the life science industry?</h3>Sterling Engineering has decades of experience working on complex, highly technical projects across various life science clients. We have streamlined our processes, best practices, and customization of manufacturing systems to meet your needs &ndash; saving you time and money.

<h1>Professional Services</h1>

Organisations may encounter various obstacles when searching for technical and engineering talent, such as:

<h3>Professional Services for Engineering providing</h3>
<h3>Temporary, Contract and Permanent Solutions.</h3>
Don&rsquo;t see what you&rsquo;re looking for? Ask us about any skill or discipline.&nbsp;

At Sterling, we pride ourselves on our exceptional recruitment process. We build strong partnerships with our clients, providing high-touch communication and in-depth prescreening to ensure the perfect match. Our advanced technology and extensive candidate database allow us to effortlessly locate technical candidates that may be difficult to find through other recruiting means. In addition, our dedicated industry-focused talent teams are profoundly knowledgeable and assess technical skills, cultural fit and alignment with our client&rsquo;s values. We also provide comprehensive onboarding support for a seamless transition and long-term success. As a result, we deliver top-notch talent that aligns perfectly with our client&rsquo;s goals and culture.

<h3>Industry Leading Staffing &amp; Recruiting</h3>

<h1>Project Management</h1>
Let&rsquo;s engineer a solution together.

<h1>Start-Up &amp; Documentation</h1>
Let&rsquo;s engineer a solution together.&nbsp;

<h1>Strategy</h1>
Let&rsquo;s engineer a solution together.&nbsp;

<h1>Transportation</h1>

<h2>JOIN OUR INTERNAL TEAM</h2>

<h1>Join Our Internal Team</h1>

<h2>Find Your Career With Sterling</h2>Sterling is fortunate to have a diverse and exceptional team of individuals with deep experience and expertise. We welcome professionals looking for new challenges, those starting their career journey and those eager to seize new opportunities in their professional lives. With Sterling, you&rsquo;ll receive:<ul><li>Full benefits</li><li>Employment opportunities that give you flexibility and new challenges</li><li>Consistent opportunities that provide stability</li><li>Expert recruiters that advocate your unique skills</li></ul>

About Owen&nbsp;
Owen Clancy is a recruitment consultant, specialising in engineering and life science talent. He manages the full recruitment lifecycle, working closely with clients and candidates to deliver strong hiring outcomes and a transparent experience.&nbsp;
With a background in HR and as an Associate CIPD member, he brings a people-focused, professional approach baked by experience in talent acquisition, employee relations and HR operations.&nbsp;
He focuses on building long-term relationships and regularly recruits for technical roles across Ireland, including engineering, quality and project management positions.&nbsp;

Owen Clancy 

About Tommy&nbsp;
Tommy McKeown is a senior recruitment consultant specialising in engineering and medical device talent across Ireland. He manages the full recruitment lifecycle, partnering closely with clients and candidates to deliver strong hiring outcomes and a seamless experience.&nbsp;
With over six years' experience in technical recruitment, Tommy brings a results-driven and market-focused approach, backed by deep knowledge of regulated industries including medtech and advanced manufacturing.&nbsp;
He focuses on building long-term relationships and regularly recruits for a wide range of roles, including R&amp;D, quality, project management and senior leadership positions such as VP Operations and Head of Engineering.&nbsp;

Tommy Mckeown

About Aidan
Aidan McNabola is a seasoned engineering professional with over 38 years of leadership experience in engineering and manufacturing, including 16 years specifically in sterile manufacturing across five sites. They have managed both direct and indirect teams of over 50 people and have extensive experience in corporate governance, including remediation, regulatory compliance and inspections. Their background also includes leading greenfield operations from startup through acquisition and overseeing projects ranging from &euro;50,000 to &euro;150 million.
&nbsp;
Career Highlights:
<ul>
<li>
Viatris Pharmaceuticals &ndash; Senior Director of Engineering. (6 years) Managed engineering activities for the Sterile filling operations. Managed the conceptual and detailed design and install of a sterile cartridge filling and assembly line . Capex value 30mill. Euros.
</li>
<li>
Taro Pharma &ndash; Engineering Manager. Managed site engineering activities for a sterile fill finish facility. Conceptual and detailed design for two new Aseptic Fill Finish Lines.
</li>
<li>
Elan Pharma &ndash; Senior Project Manager. Front end study and detailed design for a new Fill Finish facility.
</li>
<li>
Allergan Pharmaceuticals &ndash; Engineering Manager. Design, Build, start up of a new Botox facility 20Mill.
</li>
<li>
GE Healthcare &ndash; Senior Project Manager/Operations. Managed sterile filling operations. Installation of a new sterile bottle filling line and start up operations.
</li>
</ul>
&nbsp;
Education &amp; Qualifications:&nbsp;
<ul>
<li>Degree Mechanical Engineering, University Limerick</li>
<li>Chartered Eng. FIEI.</li>
<li>PMP Certified</li>
<li>Green Belt Certified</li>
<li>Level 6 Coaching Cert.</li>
</ul>

Project Process Engineer - Contract

Tommy McKeown

Project Process Engineer - Contract

Director of Operations - Quality

CNC Operator

Software Engineer

Mechatronics Engineer

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