Control Design Engineer
Posted 1 week ago by CK Group
£21 Per hour
Undetermined
Undetermined
Cambridge, England, United Kingdom
Summary: The Design Control Engineer will lead design control and risk management activities for medical device combination product development at a pharmaceutical company on a 12-month contract. The role involves ensuring compliance with quality and regulatory standards while supporting design validation and regulatory submissions. The position requires a relevant scientific degree or equivalent experience, along with knowledge of applicable standards and regulations. The role is based in Cambridge, England.
Key Responsibilities:
- Lead design control and risk management activities for medical device combination product development programmes.
- Support and facilitate effective design control and risk management activities internally and externally.
- Ensure compliance with quality and regulatory standards for medical device combination products.
- Provide input and support to design validation, including use-related risk assessments.
- Support the generation of regulatory submission data and content for assigned projects.
Key Skills:
- Relevant scientific degree or equivalent working experience.
- Working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and EU Medical Devices Regulation.
- Experience in design control and risk management for medical device combination products.
- Familiarity with Human Factors Engineering - Usability Engineering.
- Familiarity with device assembling manufacturing processes.
Salary (Rate): £20.79 hourly
City: Cambridge
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
CK Group are recruiting for a Design Control Engineer, to join a company in the pharmaceutical industry, on a contract basis for 12 months. Salary: From £16.76 to £20.79 per hour PAYE or £18.78 to £23.30 per hour UMB.
Design Control Engineer Role: Lead design control and risk management activities for medical device combination product development programmes. Support and facilitation of effective design control and risk management activities internally, at external design companies, and at the clients manufacturing facilities/CMOs. Ensure medical device combination product design control and risk management activities are compliant with quality and regulatory standards, both internal and external. Provide input and support to design validation including, but not limited to, use-related risk assessments. Support the generation of all regulatory submission data and content for assigned medical device combination product projects.
Your Background : Hold a relevant scientific degree or have equivalent working experience. Working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation. Experience in design control and risk management for medical device combination products and/or medical devices. Familiar with Human Factors Engineering - Usability Engineering. Familiar with device assembling manufacturing processes.
Company: Our client is one of the world's premier innovative biopharmaceutical companies, discovering, developing and providing over 160 different medicines, vaccines and consumer healthcare products to help improve the lives of millions of people in the UK and around the world every year.
Location: This role is based at our clients site in Cambridge .
Apply: It is essential that applicants hold entitlement to work in the UK. Please quote job reference 141 245 in all correspondence. Please note: This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.