Verification & Validation Engineer, Scientific Instrumentation

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Senior engineering role involved in test methods and strategies

The company's core technology is around rapid molecular biological applications through point-of-care diagnostics. Their ability to impact the detection of infectious diseases enables communities to stay ahead and keep populations safe. Central to their projects is a key role in verification and validation hence the recruitment of a Senior Engineer to join them.

Key responsibilities for the Senior Engineer include leading the strategy for verification activities of all aspects of the instrument and associated biological consummables; aligning test protocols with product requirements; ensuring that ISO 13485 standards are adhered to; implementing test plans and documenting via a QMS; design review procedures based on data analyses.

Requirements:

• Background in engineering (ideally a degree in mechanical or electronics engineering) including demonstrable industry experience with mechanical and electrical engineering projects.
• Recent project experience with electromechanical instrumentation (ideally for biological / clinical applications).
• Experience with verification of medical devices in an ISO 13485 regulated environment.
• Good understanding of submitting regulated products for approvals (ideally under FDA 21CFR).

Interested candidates are expected to have full, unrestricted rights to work in the UK, company sponsorship is not available. On offer is an excellent remuneration package including a wide range of benefits.

Due to the nature of the role, the position is fully onsite. Offices are based 10 miles out of Cambridge. For qualifying candidates, a season ticket loan for public transport is available. Otherwise, free secure parking is available for drivers and bike riders.

Keywords: Scientific Instrumentation, Verification & Validation, Engineering, Medical Devices, ISO 13485 / FDA 21CFR, Electromechanical, QMS Documentation, Test Strategies

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