Job Description
Job Summary:
- 6+ years of Medical devices - Design Quality experience for the projects related to Design Change, Clinical and New Product Development.
- Good experience in Medical devices regulations - ISO13485, FDA & EU MDR regulations.
- Experience in compiling Design history files & Technical file submission for 510k & CE mark.
- Own Risk Management files - Risk management plan, Hazard Analysis, DFMEA, UFMEA, Risk Management report
- Work with cross functional teams to execute and/or support various areas of Design Control processes, such as Design Input requirements, Design Outputs, Design Verification and Design Validation.
- Review & approve all the design history files with cross functional teams (including software deliverables)
- Support product development equipment qualification activities, test method development and validation activities.
- Stron...