Design Change Lead
Job type: Full-time
Employment type: Permanent
Office/Site only
Location(s)
- Sudbury - Suffolk - UNITED KINGDOM OF GREAT BRITAIN AND NORTHERN IRELAND
Responsibilities
- 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.
Qualifications
- 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.
