Senior Engineer, Manufacturing

JenaValve is a global medical device company focused on developing and manufacturing innovative Transcatheter Aortic Valve Replacement (TAVR) systems for the treatment of patients with severe aortic regurgitation and aortic stenosis.

Our mission is to raise awareness of aortic regurgitation and transform treatment options for patients living with this condition.

Our Leeds manufacturing facility produces the proprietary porcine pericardial tissue valves used within the JenaValve TAVR System.

Joining JenaValve means becoming part of a team that is dedicated to delivering high-quality medical devices and supporting advancements in patient care across the world.

We are looking for an experienced Senior Manufacturing Engineer to lead manufacturing engineering and process development activities associated with transcatheter heart valve production.

This role is responsible for developing and optimising manufacturing processes, supporting production scale-up, improving yield and capacity, and ensuring compliance with medical device regulations and quality requirements.

Working closely with Manufacturing, Quality and R&D teams across JenaValve, you will play a key role in delivering process improvements, validating manufacturing systems and supporting the successful commercialisation and ongoing manufacture of life-changing medical devices.

• Leading manufacturing process development and optimisation activities for THV production.
• Supporting production scale-up through capacity planning, line balancing and process improvement initiatives.
• Analysing manufacturing KPIs and developing continuous improvement projects to improve throughput, yield and efficiency.
• Investigating manufacturing issues using structured problem-solving methodologies including 8D, DMAIC, Fishbone Analysis and 5 Whys.
• Partnering with Manufacturing, Quality and R&D teams across multiple sites to develop and validate critical manufacturing processes.
• Conducting root cause investigations to identify opportunities for process optimisation and operational improvement.
• Applying Lean Manufacturing and Six Sigma methodologies to drive productivity and quality improvements.
• Designing and developing tooling, assembly jigs and fixtures to support manufacturing operations.
• Supporting test method validation activities with consideration for quality, cost and yield.
• Managing manufacturing equipment activities including qualification, validation (IQ, OQ and PQ), calibration and preventative maintenance.
• Developing training materials, work instructions and manufacturing documentation.
• Supporting Quality Management System documentation, change controls, regulatory submissions and equipment management activities.
• Supporting the investigation and resolution of complex manufacturing, quality and compliance issues, including CAPAs and non-conformances.
• Providing technical leadership and guidance to engineers and technicians.
• Coaching, mentoring and developing less experienced employees.
• Leading complex projects, including project planning, risk management and stakeholder engagement.
• Designing and executing experiments and validation activities, analysing results and preparing technical reports.
• Supporting internal quality audits and regulatory compliance activities.
• Maintaining accurate records and ensuring compliance with all Quality Management System requirements.
• Supporting company Health, Safety and Environmental objectives.
• Undertaking other reasonable duties requested by management.

• A Bachelor's degree in Mechanical Engineering, Biomedical Engineering or a related engineering discipline.
• A minimum of five years' experience within a medical device manufacturing environment or another highly regulated industry.
• Proven experience supporting production scale-up from low-volume to medium or high-volume manufacturing.
• Lean Manufacturing certification and/or Six Sigma Green Belt qualification (or higher).
• Strong knowledge of:
• Lean Manufacturing
• Six Sigma methodologies
• Process validation
• Risk management
• Statistical analysis
• New equipment introduction

• Experience of equipment qualification, process validation and design verification activities within regulated industries.
• Strong project management and stakeholder management experience.

The following would be advantageous:

• Experience within heart valve, catheter, stent, delivery system or other interventional medical device manufacturing.
• A Master's degree in Engineering.
• Formal project management certification.

• Strong manufacturing engineering expertise within a regulated environment.
• Excellent project management and organisational skills.
• A practical, hands-on approach to problem solving and process improvement.
• Strong analytical and investigation skills.
• Experience applying Lean Manufacturing and Six Sigma methodologies to achieve measurable improvements.
• Excellent communication skills with the ability to explain technical concepts to both technical and non-technical audiences.
• Strong technical documentation and report-writing capabilities.
• The ability to manage multiple priorities while maintaining a high level of attention to detail.
• Strong stakeholder management and cross-functional collaboration skills.
• Knowledge of GMP requirements and regulatory procedures within the medical device industry.
• Strong interpersonal and relationship-building skills.
• The ability to work effectively across different teams, functions and time zones.
• A proactive approach to coaching and developing others.

Salary: from £50,000 - subject to experience

Benefits:

• Company pension
• Free parking
• Private medical insurance
• Employee Referral program
• Company sick pay
• 28 days holiday plus public holidays
• Discretionary corporate bonus