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Software Engineer
Ref No.: 18-52135
Location: Pleasanton, California
Position Type:Contract
Start Date: 07/24/2018
Design Controls: • 6 years of 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)
Embedded Design, C, C++, Linux, Good understanding of IEC 62304, Understanding of Software design and architecture concepts.