At a Glance
- Tasks: Lead design changes for medical devices, ensuring compliance and timely delivery.
- Company: Join a pioneering healthcare company that values diversity and individuality.
- Benefits: Enjoy 26 days' holiday, flexible benefits, and a generous pension scheme.
- Other info: Opportunities for professional growth and community involvement through volunteering.
- Why this job: Make a real impact in healthcare while growing your skills in a supportive environment.
- Qualifications: Experience in leading design changes in regulated environments and strong organisational skills.
The predicted salary is between 50000 - 65000 £ per year.
Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.
Apply now for the position of Design Change Lead, and you will lead end-to-end design changes for medical devices, ensuring changes are delivered safely, compliantly, and on time in line with applicable quality and regulatory requirements.
Your Role
- You will lead cross-functional design change execution from initiation to closure (ECR/ECO), coordinating R&D, Quality, Regulatory, Manufacturing, Supply Chain, and Service.
- You will ensure design changes follow design control requirements, maintaining clear traceability across user needs, design inputs/outputs, verification/validation, and design review evidence.
- You will lead change impact and risk assessments, defining risk controls and ensuring residual risk is acceptable and documented.
- You will plan and drive verification and validation activities for design changes, ensuring test strategy, protocols, reports, and objective evidence support intended use and regulatory submissions as required.
- You will ensure timely updates to the technical documentation, drawings/specifications, IFU/labelling (where applicable), and associated records under document control.
- You will ensure manufacturing readiness for released changes (process updates, supplier alignment, inspection methods, training) and support implementation, effectiveness checks, and linkage to CAPA/complaints as needed.
Your Expertise
- You have experience leading design changes in a highly regulated environment, including cross-functional change governance and implementation.
- You have strong working knowledge of design controls and regulated quality management system expectations.
- You can influence and align stakeholders at all levels, facilitating design reviews and driving timely decisions in a matrix organisation.
- You have experience planning/overseeing verification and validation, and maintaining robust technical documentation.
- You understand manufacturing and supplier change implementation, including process validation impacts, inspection strategies, and working effectively with CAPA/complaints and post‑market feedback.
- You bring strong organisation and delivery focus, attention to detail, and a continuous improvement mindset, with the ability to manage multiple changes in parallel.
Benefits
- 26 days' holiday with the option to buy or sell an additional 10
- Up to 10% employer pension contribution
- Share and bonus scheme
- Access to our flexible benefits from private medical insurance to dental cover
- Corporate Social Responsibility opportunities including 2 paid volunteering days per year and support from our 24/7 employee assistance programme
As an equal opportunity employer, we welcome applications from individuals with disabilities.
