Metrology Engineer

We are seeking an experienced Metrology Engineer to join our clients Engineering team and provide a high-quality metrology service supporting both commercial manufacturing and New Product Introduction (NPI) activities.

The role will have a strong focus on measurement system development, qualification, calibration, dimensional inspection, tooling development and continuous improvement. You will work closely with Engineering, Quality, Manufacturing, R&D and external suppliers to ensure measurement systems and processes are robust, efficient and compliant within a highly regulated manufacturing environment.

The successful candidate will have a high level of autonomy and will be expected to demonstrate strong technical expertise, analytical capability and a proactive approach to problem solving and continuous improvement.

Key Responsibilities
Metrology & Measurement Systems

• Provide metrology and analytical support for moulded component batch release and engineering studies.
• Develop, maintain, troubleshoot and optimise measurement systems and equipment.
• Develop and qualify measurement systems for new product introductions in line with project timelines.
• Develop and maintain measurement routines, either internally or through external contractors.
• Design and qualify instrument-generated measurement reports in accordance with data integrity requirements.
• Carry out dimensional inspection and statistical analysis of measurement results.
• Coordinate Gauge R&R and Measurement System Analysis (MSA) activities, including statistical analysis and report generation.
• Generate and maintain metrology documentation supporting equipment, fixtures and measurement systems.
• Develop calibration and preventive maintenance requirements for metrology equipment.
• Support the specification, evaluation and selection of new metrology equipment.
• Troubleshoot metrology equipment, fixtures and measurement routines to improve quality, reliability and efficiency.

NPI, Tooling & Fixture Development

• Provide metrology support throughout New Product Introduction projects.
• Support tooling development through dimensional measurement and analysis.
• Assess component drawings for suitability for dimensional inspection.
• Provide recommendations to design teams to improve the inspectability and measurement of component features.
• Participate in cross-functional Design for Excellence (DfX) workshops.
• Design and develop prototype inspection fixtures for evaluation through Gauge R&R.
• Participate in fixture design reviews prior to manufacture.
• Communicate learnings from prototype fixtures to fixture manufacturers for incorporation into final designs.
• Introduce and qualify fixtures in accordance with project timelines and budgets.
• Oversee tooling development measurements and provide technical feedback to relevant stakeholders.

Validation, Compliance & Documentation

• Generate validation documentation, including Installation Qualification (IQ) and Operational Qualification (OQ), for new metrology equipment.
• Ensure metrology systems and processes comply with applicable quality, regulatory, data integrity and company requirements.
• Support internal, external, corporate and regulatory audits.
• Prepare and implement CAPA plans where required.
• Maintain appropriate technical and quality documentation.
• Ensure all activities are performed in accordance with applicable cGMP, ISO, FDA and company requirements.

Data Analysis & Continuous Improvement

• Conduct statistical analysis of dimensional inspection data from moulding runs, tooling studies and NPI activities.
• Identify opportunities to improve measurement systems, manufacturing processes and overall equipment performance.
• Lead or contribute to metrology and manufacturing cost improvement initiatives.
• Identify opportunities to improve efficiency, reduce equipment downtime and maximise output and yield.
• Investigate measurement and manufacturing issues and implement effective corrective and preventive actions.
• Promote a continuous improvement and Right First Time culture.

Project & Stakeholder Management

• Manage and coordinate internal and external metrology projects.
• Develop and maintain metrology schedules and capacity plans.
• Monitor project progress against agreed timelines, budgets and deliverables.
• Present project updates and technical information to stakeholders and management.
• Liaise with Engineering, R&D, Quality, Manufacturing, suppliers and external contractors.
• Supervise external contractors and coordinate their activities as required.
• Support the preparation of capital expenditure requests for metrology equipment and related projects.
• Manage relevant project budgets within agreed targets.
• Negotiate with external suppliers to achieve appropriate cost, quality and delivery requirements.
• Prepare management reports and technical documentation as required.

Health, Safety & Environment

• Comply with all relevant Health, Safety and Environmental policies and procedures.
• Demonstrate safe working practices and promote a strong EHS culture.
• Remain aware of personal safety and the safety of colleagues and contractors.
• Report incidents, near misses and unsafe conditions promptly through the appropriate systems.
• Participate in EHS improvement initiatives.
• Complete all required EHS training and medical surveillance programmes.
• Use appropriate PPE and follow all site safety requirements.

Skills & Experience
Essential

• Minimum Level 7 qualification in Engineering or a related discipline.
• 2+ years' experience in metrology, measurement engineering, quality engineering or a similar technical role.
• Experience within medical device, pharmaceutical, combination product or another highly regulated manufacturing environment.
• Practical experience with measurement systems, dimensional inspection and calibration.
• Experience with Gauge R&R / MSA and statistical analysis.
• Strong analytical and problem-solving skills.
• Experience interpreting engineering drawings and dimensional specifications.
• Experience working with inspection fixtures, tooling or measurement routines.
• Understanding of quality systems and regulated manufacturing requirements.
• Strong technical documentation and report-writing skills.
• Excellent communication and stakeholder management skills.
• Ability to work independently and manage multiple priorities.

Desirable

• Experience with CMMs and/or automated dimensional inspection systems.
• Experience developing CMM or other measurement routines.
• Knowledge of metrology equipment qualification, including IQ/OQ.
• Experience with calibration and preventive maintenance systems.
• Knowledge of statistical tools and techniques used for measurement and process analysis.
• Experience supporting NPI and tooling development projects.
• Experience with data integrity requirements in a regulated environment.
• Experience working with external suppliers and contractors.
• Knowledge of cGMP, ISO and FDA requirements.

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