Job Description

• 5 years experience in Medical devices design & development, especially cardio vascular products
• Good understanding of ISO13485 & ISO14971 standards
• Experie• 5 years experience in Medical devices design & development, especially cardio vascular products
• Gnce 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)