Trainer, THV Sewing - PM Shift

JenaValve is a privately owned medical device company focused on the design and manufacture of Pericardial Transcatheter Aortic Valve Replacement (TAVR) Systems, intended to treat patients with Symptomatic, Severe Aortic Regurgitation and Stenosis.

Our production site in Leeds, manufactures the proprietary porcine pericardial heart valve used in the JenaValve Pericardial TAVR System.

The Trainer supports the Team Leader and Specialist Trainers with onboarding new employees and cross-training existing team members in transcatheter heart valve assembly within clean room environments. The role includes supporting structured training plans, assisting with the reporting and tracking of training-specific KPIs, and monitoring training effectiveness to ensure alignment with performance goals and operational standards. 

Working in compliance with the Quality Management System (QMS), the Trainer provides hands-on production support to reinforce learning, ensure consistency, and promote process excellence. As a representative of the company culture, the Trainer also acts as an ambassador for the organisation's values, helping to create a positive and professional environment for new team members.

• Support and implement structured training plans for new hires and cross-training programs for existing employees in clean room transcatheter heart valve assembly operations.
• Deliver hands-on coaching, mentoring, and ongoing support to technicians at all levels to reinforce best practices and technical excellence.
• Act as an ambassador for company core values, setting the tone for professionalism, teamwork, and quality throughout the onboarding and training experience.
• Participate in the production of transcatheter heart valves in full compliance with the JenaValve Quality Management System (QMS).
• Ensure that all training and production activities are properly documented, and that necessary materials and resources are available and compliant.
• Proactively identify and resolve issues related to Good Documentation Practices (GDP), process deviations, and product quality, escalating as necessary.
• Work closely with the Team Leader and Specialist Trainers to prioritize workflow, identify training needs, and support daily manufacturing objectives.
• Act as a point of escalation for production-related queries, technical issues, and documentation concerns, providing timely solutions and guidance.
• Participate in problem-solving and continuous improvement efforts, and supporting QMS activities such as NCRs and CAPAs.
• Provide direct, constructive feedback on workmanship, procedural adherence, and quality of output during training and routine production.
• Support the development and scale-up of new products and process variants, including training support for process changes.
• Maintain accurate and up-to-date training and production records, including transcatheter heart valve assembly documentation.
• Promote and ensure adherence to all Environment, Health & Safety (EHS) regulations, and take an active role in creating a safe work environment.

• Must have training skills, work independently and the ability to motivate others. 
• Experience interacting with quality, and training. 
• Attention to detail and the ability to work in a fast-paced environment is key. 
• Must have excellent written and verbal communication skills. 
• Must take initiative and have the ability to prioritize workload for self and others. 
• Must be able to work effectively and collaborate within cross functional teams. 
• Must possess the ability to handle multiple tasks, with high attention to detail, associated with document processing and task-based processes relating to a clean room environment. 
• Must have good working knowledge of Microsoft Office packages.
• Must understand good manufacturing practices (GMP) and be able to work in a controlled environment.

• Minimum 3 years of experience in:
• Medical device manufacturing
• GMP and clean room environments
• GCSE or equivalent
• Has high standard of workmanship and speed. 
• Experience of on-the-job training in heart valve tissue processing manufacturing required. 
• Knowledge of pericardial tissue and valve quality procedures, equipment and tools used in the medical device industry or other regulated industries is required. 
• Familiar with 21CFR820 and ISO 13485 requirements.

Salary: £39,598 plus PM Shift Bonus

Benefits:

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