💼 Full-Time Position

Principal Design Quality Engineer (DHF)

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Katalyst Healthcares & Life Sciences
📍 Maple Grove, Minnesota, United States
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Location
Maple Grove, Minnesota, United States
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Posted
May 14, 2026
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Type
Full-Time
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Full-Time Opportunity: This is a permanent, full-time position with a competitive package and real career growth potential.

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:

  • 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...