Staff Engineer, Quality - PM Shift

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 Staff Engineer, Quality to provide technical quality leadership across new product development, commercial manufacturing and product commercialisation activities.

This role is responsible for delivering Quality Engineering support throughout the product lifecycle, ensuring compliance with international Quality Management System standards and regulatory requirements, including the European Medical Device Regulation (EU MDR 2017/745).

You will work closely with Engineering, Manufacturing, Regulatory Affairs and Quality teams to support the successful development, transfer and ongoing manufacture of innovative medical devices whilst maintaining the highest standards of quality, compliance and patient safety.

This role will be working an afternoon shift of 2pm to 10pm, Monday to Friday.

As a Staff Engineer, Quality, your responsibilities will include:

• Acting as the Quality representative within New Product Development project teams.
• Managing quality-related aspects of development projects and ensuring compliance throughout the product lifecycle.
• Critically reviewing and approving design changes for heart valves and delivery catheter systems.
• Providing technical quality support for pilot production and clinical manufacturing activities.
• Partnering with Manufacturing Engineering teams to develop and improve critical manufacturing processes.
• Leading root cause investigations into product and component non-conformances.
• Developing and implementing corrective and preventive actions.
• Providing quality leadership for design verification, design validation, design transfer and design control activities.
• Developing, reviewing and approving product and process change documentation.
• Acting as a Subject Matter Expert within the Quality Management System.
• Coordinating cross-functional activities requiring input from multiple departments.
• Ensuring product, process and design changes remain compliant with EU MDR requirements.
• Supporting conformity assessment activities, technical documentation reviews and Notified Body submissions.
• Providing quality engineering support to commercial manufacturing operations, including process monitoring, change control and non-conforming material disposition.
• Supporting process validation activities, including IQ, OQ and PQ protocols.
• Participating in internal audits, supplier quality activities and CAPA investigations.
• Supporting post-market surveillance and vigilance reporting activities.
• Coaching and mentoring less experienced colleagues.
• Supporting continuous improvement initiatives across Quality and Manufacturing functions.
• Undertaking other reasonable duties requested by management.

• A Bachelor's degree in Mechanical Engineering, Biomedical Engineering or a related engineering discipline.
• Significant Quality Engineering experience within medical device new product development.
• A minimum of ten years' experience within the medical device industry.
• Experience working within regulated Quality Management Systems.
• Strong knowledge of:
• ISO 13485
• ISO 14971
• 21 CFR Part 820
• EU Medical Device Regulation (EU MDR 2017/745)
• Experience supporting manufacturing operations within a regulated environment.
• Experience of process validation, change control and production quality support would be advantageous.
• Knowledge of equipment qualification and design verification activities within regulated industries would be beneficial.

• Strong technical quality engineering expertise within the medical device sector.
• Excellent problem-solving and root cause analysis skills.
• Strong project management and technical documentation capabilities.
• Excellent risk management skills.
• Strong statistical analysis and data interpretation skills.
• The ability to manage multiple priorities whilst maintaining exceptional attention to detail.
• A proactive, hands-on approach to delivering quality solutions.
• Strong written and verbal communication skills.
• The ability to communicate complex technical information to both technical and non-technical audiences.
• Experience presenting information to customers, auditors and business stakeholders.
• Strong collaboration and relationship-building skills across cross-functional teams.
• A solid understanding of mechanical systems and engineering principles.
• The ability to work independently while influencing and supporting wider project teams.

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