Design Control Engineer

CPL Life Sciences are looking to recruit a Design Controls Engineer to join a global Pharmaceutical company based in Cambridge.

This will be a 12 month contract role (PAYE), based on site in Cambridge.

Responsibilities:

• 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

Skills & experience:

• 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).

If interested, please apply directly or email your CV to megan.smyth@cpl.com