Position Overview
Job Summary:
Principal Design Quality Engineer (Design History Files) - They will be reviewing the entire catalogue of implantable device DHF's to ensure compliance.
Required Qualifications:
Bachelor's degree in mechanical engineering, Biomedical Engineering or related Engineering field of study.
Minimum of years of experience in design assurance, quality, or related medical device or regulated industry experience (Experience with Class III Medical Devices preferred).
Experience in new product development such as driving and creating risk management deliverables (risk management plan/report, hazard analysis, task analysis, dFMEA, etc.), validating test methods, supporting the creation of design requirements, design verification and validation.
Experience in developing test methods.
Gap assessment and remediation.
Experience with a product development team in design quality.
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