Project Manager

About the Opportunity

Our client is a leading organisation within the medical device sector, specialising in the development and manufacture of innovative catheter-based medical technologies.

We are currently seeking an experienced Project Manager to lead customer development programmes for Class II and Class III medical devices, taking projects from initial concept through to commercialisation.

This is a highly visible, customer-facing role that combines technical leadership, programme management, commercial responsibility, and stakeholder engagement. The successful candidate will bring strong experience in catheter-based medical device development, together with the ability to lead cross-functional teams and build trusted relationships with customers.

The Role

As Project Manager, you will act as the primary customer-facing leader for assigned development programmes. You will work closely with customers to understand their requirements, translate those needs into clear technical and project objectives, and lead multidisciplinary teams through the product development lifecycle.

You will collaborate closely with Engineering, Quality, Operations, Supply Chain, Production, Finance, and Business Development to ensure programmes are delivered on time, within agreed scope and budget, and in accordance with applicable regulatory and quality requirements.

Key Responsibilities
Customer & Stakeholder Leadership

• Act as the primary customer contact and relationship owner for assigned development programmes.
• Lead customer meetings, technical reviews, project updates, and executive presentations.
• Translate customer requirements into clear technical, commercial, and project requirements.
• Build strong, long-term customer relationships and proactively manage expectations around scope, timelines, deliverables, and risks.
• Support business development activities, including opportunity assessments, customer visits, proposal reviews, and technical presentations.
• Communicate project status, risks, issues, and key decisions clearly to both customers and internal stakeholders.

Technical Leadership

• Partner with technical and engineering leaders to develop catheter-based medical devices, including balloon catheter technologies, braided shaft technologies, delivery systems, and associated catheter platforms.
• Lead multidisciplinary teams through concept development, design reviews, risk management, Design Verification (DV), Design Validation (PV/clinical readiness), and design transfer.
• Provide technical leadership and support in resolving complex product development challenges.
• Ensure development solutions meet customer, regulatory, quality, and manufacturing requirements.
• Provide oversight of verification and validation strategies, execution, and reporting.
• Apply knowledge of active medical devices and associated development requirements where applicable.

Programme & Project Management

• Lead projects through all phases of the medical device product development lifecycle.
• Develop and manage project scope, schedules, budgets, resources, milestones, and deliverables.
• Drive cross-functional execution across Engineering, Quality, Operations, Supply Chain, and Production.
• Identify, assess, and proactively manage programme risks, issues, dependencies, and changes.
• Ensure projects are delivered in accordance with applicable FDA Design Control, ISO 13485, risk management, and internal product development requirements.
• Provide accurate and timely project reporting, escalation, and portfolio updates.

Commercial & Contract Management

• Develop, review, and support negotiation of Statements of Work (SOWs) with customers.
• Define project scope, assumptions, deliverables, milestones, and timelines.
• Manage scope changes and contractual obligations throughout programme execution.
• Support quotation development, project costing, forecasting, and commercial decision-making.
• Partner with Business Development and Finance to ensure programme objectives align with both customer requirements and business objectives.

Quality & Operational Responsibilities

• Maintain accurate project documentation, customer records, budgets, forecasts, status reports, and portfolio information.
• Ensure project records support quality system requirements and audit readiness.
• Contribute to continuous improvement initiatives focused on project execution, product development, and operational effectiveness.

About You

You will ideally have:

• A Bachelor's degree in Engineering or a related technical discipline.
• 10+ years' experience within the medical device industry.
• Demonstrable experience developing Class II and Class III medical devices.
• Significant customer-facing experience, including technical presentations, project reviews, and stakeholder management.
• Strong experience in catheter-based medical device development, particularly balloon catheter technologies, braided shaft technologies, or both.
• Proven experience leading Design Verification (DV) and Design Validation (PV/clinical readiness) activities.
• Knowledge of active medical devices and associated development processes.
• Strong understanding of FDA Design Controls, ISO 13485, risk management, and regulated product development methodologies.
• Demonstrated experience managing project scope, schedules, budgets, resources, risks, and deliverables.
• Experience developing Statements of Work and supporting commercial/contract negotiations.
• Excellent communication, presentation, negotiation, influencing, and leadership skills.

Desirable Experience

• Previous experience working within a medical device CDMO environment.
• PMP or equivalent project management certification.
• Experience working across international customer and stakeholder groups.
• Experience taking medical device programmes from concept through to commercialisation.

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