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RisK Engineer
Ref No.: 18-52076
Location: Pleasanton, California
Position Type:Contract
Start Date: 07/24/2018
Risk Management: • 5+ years of experience in Medical devices design & development, especially cardio vascular products • Good understanding of ISO13485 & ISO14971 standards • Experience in creating Risk Management plan, Hazard Analysis, DFMEA, PFMEA, Use FMEA, Software Hazard Analysis, Risk Management Report • Experience in creating risk controls and Overall Residual Risk Evaluation • Experience in updating risk management files based on post market surveillance feedback like complaints • Mapping complaint codes with risk files • Excellent communication skills (verbal and presentation skills)