Manager, THV Production

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 Production Manager who can lead and develop the Production Team at our Leeds manufacturing site.

This is a hands-on leadership position with responsibility for the effective planning, organisation, training and management of THV production activities. You will provide operational oversight of THV builds and technical training, while supporting manufacturing and research and development activities associated with new product development and commercialisation.

You will work closely with Manufacturing Engineering, Quality Engineering, Quality Assurance, Planning and other cross-functional teams to achieve production, quality, cost and employee-development objectives.

The successful candidate will champion positive change across the manufacturing process and help drive technical and operational improvements.

You will promote a culture grounded in quality, mistake-proofing, regulatory compliance, continuous improvement, Lean Manufacturing and Six Sigma principles.

• Leading, developing and managing the THV Production Team, ensuring that employees have the training, direction and support required to perform their roles effectively.
• Setting clear departmental goals and expectations and providing regular performance feedback to employees.
• Leading production meetings with Engineering, Planning, Quality and other support functions.
• Prioritising projects and coordinating cross-functional support to resolve production issues effectively.
• Prioritising production schedules based on product introduction requirements, equipment efficiency and material availability.
• Delivering production objectives measured through plan versus actual performance, yield, cost, quality and labour.
• Ensuring consistent operational practices across the value stream.
• Creating, implementing and monitoring training plans that support production and quality objectives.
• Maintaining compliance with applicable regulatory, environmental, health and safety requirements and approved manufacturing procedures.
• Promoting a quality-focused culture and monitoring compliance with Quality System requirements, including Good Manufacturing Practice, Good Documentation Practice, non-conforming material controls, product holds and line clearance.
• Participating in Material Review Board activities relating to production disposition.
• Working in partnership with Quality Engineering, Manufacturing Engineering and Quality Assurance to monitor departmental quality performance and support corrective actions.
• Supporting root-cause investigations relating to component and device non-conformances.
• Supporting process development and validation activities for new product introductions and continuous improvement projects.
• Assisting with the development of assembly methods and manufacturing procedures where required.
• Proactively identifying health and safety concerns and ensuring that open incidents are addressed appropriately.
• Participating in quality and operational improvement activities, including Lean Six Sigma projects.
• Creating a positive working environment focused on quality, compliance, employee development and collaboration.
• Using appropriate recognition and motivational approaches to support employee engagement and satisfaction.
• Managing employee performance and ensuring that any necessary remedial actions are addressed promptly and appropriately.
• Developing and implementing production-area activities that support production, quality and cost objectives.
• Supporting the planning and administration of departmental procedures and budgets.
• Making budgetary recommendations relating to capital expenditure and direct and indirect labour.

• A bachelor’s degree in a relevant field.
• A minimum of six years’ experience supervising or managing employees within a highly regulated manufacturing environment.
• Experience within the medical device industry, supported by relevant manufacturing, quality or product-development engineering experience.
• Previous responsibility for people management and employee relations matters.
• Experience of working collaboratively within cross-functional teams.
• Practical experience of implementing Lean Manufacturing and Six Sigma concepts.

• Strong people leadership, coaching and team-development skills.
• The ability to set clear expectations, provide constructive feedback and build a culture of positive reinforcement.
• Confidence in managing performance and addressing conduct or capability concerns when required.
• Excellent attention to detail and the ability to work effectively in a fast-paced and changing manufacturing environment.
• A results-focused approach, with personal accountability and ownership of projects and deliverables.
• The ability to analyse and adjust production-line or operational layouts to improve efficiency.
• Experience designing and delivering effective training plans.
• Strong practical and technical skills, with the judgement required to address complex technical problems.
• Experience leading small project teams and coordinating cross-functional activity.
• Excellent written and verbal communication skills, with the ability to communicate clearly and directly.
• Strong relationship-building, collaboration, influencing, negotiation and conflict-resolution skills.
• The ability to balance the needs of different functions and help stakeholders reach an effective consensus.
• Working knowledge of Microsoft Office applications and Enterprise Resource Planning systems.
• Experience of QAD would be beneficial.

Salary:

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