Location
Maple Grove, Minnesota
Job Type
Full-time
Posted
May 14, 2026
Job Description
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:
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 6 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 develop...
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