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Risk Engineer
Ref No.: 18-60248
Location: Sylmar, California
Position Type:Contract
Start Date: 08/01/2018

· 5 years 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)