Medical Device Expert
Ref: J000384
Location: Hertfordshire
Salary: £40 - 55k

Our client is a world-class organisation providing services for medical device manufacturers around the world. Its diverse and experienced team has an in-depth knowledge and understanding of complex medical device technologies.

We are looking for device experts with an industrial, clinical or academic background to review and assess critical design data (including risk analysis, biocompatibility, clinical investigation data and post market surveillance information). Depending on your skills base you will work in the area of active medical devices, medical device software or medical device telemetry.

Key skills and experience:-
o Medical device experience within an industrial, academic or clinical background.
o Sound academic background in physics or electronics
o Knowledge of relevant harmonised standards covering medical devices, such as the EN 60601 series
o Experience in one or more of the following areas:-
o Electronics engineer specialising in communications.
o Knowledge of regulations and standards relating to radio communications.
o Experience of active medical devices incorporating telemetry systems.
o Knowledge of the regulations and standards relating to programmable electronic systems, software lifecycle management and risk management.
o Experience of working in software development, preferably on medical devices. Capable of reviewing technical documentation/design dossiers for active medical devices, including the software needed for its operation.
o Quality Management Systems - Capable of site assessment of active device manufacturers including design controls and software development processes.
o A thorough understanding of the technological considerations and manufacturing processes relevant to the field in which they have worked:
o It would be an advantage to be familiar with the European medical devices approval process.

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