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Product Engineer 3
Ref No.: 18-10833
Location: Norwood, Massachusetts
Start Date / End Date: 08/27/2018 to 02/25/2019
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.