Job Description :
Responsibilities:

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, IEC60601-1 , 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.
             

Similar Jobs you may be interested in ..