Principal Design Assurance Engineer / Quality Assurance

Real Resourcing
02 Dec 2017
08 Dec 2017
Contract Type
Full Time
I am partnering with an industry leading business specialising in the design and development of a range of exciting Medical Devices to find a Senior Design Assurance Engineer / Senior Quality Engineer to be based in Cambridge.

You will apply your regulatory knowledge to device development projects across any of the Division's four focus areas, liaising with scientists, engineers and Quality Assurance personnel both within the organisation & external partners.

Key Responsibilities:

* Design Reviews to assess quality and compliance
* Review requirements for traceability and testability
* Lead product risk management activities according to ISO14971 (including creation of Risk Management Plan, FMECAs, Fault Tree Analysis and Risk Management Report)
* Plan verification programmes, including interpretation and implementation of relevant standards, and establishment of acceptance criteria
* Perform analysis and interpretation of test data, including statistical analysis where necessary
* Help clients optimise their medical development processes
* Supporting creation of Technical Files / Design History Files
* Including review of client's Technical File / Design History Files
* Perform gap analysis against quality system and regulatory requirements

Required Skills & Experience:

* A good degree in Engineering or related technical discipline
* Experience of working in multi-disciplinary teams
* Significant experience of risk management with regard to Medical Product development (according to ISO14971)
* Excellent understanding of medical device directive 93/42/EEC, ISO13485 and FDA QSR
* Experience of Design Verification

Desirable Skills & Experience:

* Knowledge and experience of implementing IEC 60601
* Knowledge and experience of implementing IEC 62304
* Experience of liaising with the US FDA with regards to device submissions
* Experience of Design Validation
* Experience of design and development of, and regulatory submission for combination products / borderline products
* Experience of regulatory requirements regarding testing of pharmaceuticals

If this is an opportunity that aligns with your experience and career aspirations, please call Lillie Fenlon-Billson on Phone number removed or email me at l.fenlon-billson at

Sthree UK is acting as an Employment Agency in relation to this vacancy.