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Design Control Engineer`
Ref No.: 18-60247
Location: Sylmar, California
Position Type:Contract
Start Date: 08/01/2018
·         6 years experience in Medical devices design & development, especially cardio vascular products
·         Experience in working in Medical device - New product development & DHF Remediation projects
·         Good understanding of ISO13485 & ISO14971 standards, 21 CFR Part 820 & EU MedDev Regulations
·         Experience in creating Design inputs / requirements, Design outputs, Design verification & Validation
·         Experience in Trace Matrix (DOORS is optional)
·         Good understanding on product specific standards & safety standards
·         Good understanding on product sterility, biocompatibility, labeling & packaging standards
·         Experience in creating Risk Management plan, Hazard Analysis, DFMEA, PFMEA, Use FMEA, Software Hazard Analysis, Risk Management Report
·         Experience in updating risk management files based on post market surveillance feedback like complaints
·         Excellent communication skills (verbal and presentation skills)