Job Description

• 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)