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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. Strong in Medical devices technical documentation Excellent verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization. Strong analytical/problem solving, critical thinking, and presentation skills.