Reliability Engineer
SoftHQ, Inc. - Minneapolis, MN

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Expert in performing Process FMEA Design FMEA System FMEA and Hazard Analysis Expert in performing FTA Hazard Analysis and Root cause analysis Hands on experience in ISO 14971 IEC 800011 and IEC 60812 Skilled in suggesting mitigation for identified Hazards and contingency plan for occurred hazards In depth knowledge about Active medical devices and its parameter functionality Good Knowledge of General Collateral and particular standards of Medical devices Experience in Accelerated testing – HALT HASS Experience in Environmental Testing includes shock vibration Ingres Protection tests Good Knowledge of IEC 606011 3rd edition ISO 13485IEC 62304 and IEC 62366 Experience in analysis of field failure data and recommending for productprocess improvement Five years of experience in Bio medical field Expert in Reliability and Product Risk Analysis Relevant 5 years experience in entire development cycle of medical devices and performing Risk Management activities To apply for this position please send resumes to andresofthqcom mailtoandresofthqcom Process FMEA