- 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).
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Verification & Validation Engineer, Scientific Instrumentation - Cambridge, Cambridgeshire, United Kingdom - Ecm Selection
Description
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:
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
Please note: even if you don't have exactly the background indicated, do contact us now if this type of job is of interest - we may well have similar opportunities that you would be suited to. And of course, we always get your permission before submitting your CV to a company.
Recommend for £250 - see for details.
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