Product Engineer

Position: Product Engineer
 Location: Norwood, MA
Duration: 12 months (Extendable)
 
Description:
Senior Risk Management Engineer - Performs complex analysis on risk management files. Facilitates cross function risk management sessions, updates risk management plans, reports and Hazard Analysis. Responsible for global procedure updates. Will be responsible for new IVDR requirements. 
 
 Must have: 
 BS or MS in engineering degree, biomedical desired. 
 FMEA, HA, FTA experience and training 
 8 years experience in Risk Management 
 Expert knowledge of ISO 14971 and risk management in IVDD, IVDR 
 Experience with multiple projects. 
 Medical device experience highly desired. 
 Demonstrated experience driving a successful Risk Management Process.

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