Design Controls Engineer
- Cambridge
- Temporary
- Full-time
- Lead design control and risk management activities for medical device combination product development
- Support effective design control and risk management activities internally, at external design companies, and at related manufacturing facilities/CMOs
- Generate and approve documentation, ensuring compliance with quality & regulatory standards (internal & external)
- Provide support to design validation
- Support in internal & external audits where required
- Hold a relevant degree or proven experience working in a similar role
- Understanding of working to ISO 13485/ISO 14971/21 CFR 820/21 CFR 4, and the EU Medical Devices Regulation.
- Experience in medical device combination products and/or medical devices
- Understand Good Manufacturing Practices (GMP).