Design Quality Engineer

Now Hiring: Design Quality Engineer

Location: Maple Grove, MN (Onsite)

Pay Rate: Up to $54.00/hour

We are seeking a Design Quality Engineer to support a critical Design History File (DHF) remediation project focused on Design Assurance activities within a regulated medical device environment. This role is ideal for an experienced quality engineer with strong design controls, risk management, and Medical Electrical Equipment (MEE)/capital equipment experience.

Key Responsibilities

• Support DHF remediation activities, including gap assessments, documentation updates, and design control compliance.
• Develop, review, and maintain design history files, design inputs/outputs, specifications, and traceability documentation.
• Lead updates to risk management documentation, including DFMEA and Hazard Analysis.
• Ensure alignment between design requirements, risk controls, verification, validation, and product documentation.
• Partner with cross-functional teams including Engineering, Manufacturing, Regulatory Affairs, and Document Control.
• Support audit and inspection readiness through organization of objective evidence and remediation records.
• Identify quality and compliance risks and drive resolution activities.

Required Qualifications

• Minimum 3+ years of medical device industry experience.
• Required experience with Design Controls, DHF remediation, and Medical Electrical Equipment (MEE)/Capital Equipment.
• Strong knowledge of DFMEA, Hazard Analysis, risk management, and design documentation.
• Experience creating, updating, and maintaining Design History Files and Design Input/Output documentation.
• Working knowledge of IEC 60601, ISO 14971, ISO 13485, and 21 CFR Part 820.
• Must be located in Minnesota and able to commute to Maple Grove.
• Candidates must be authorized to work in the U.S. without current or future sponsorship.

Employee Benefits

• Medical, dental, vision, and pet insurance
• 401(k) Retirement Savings Plan
• Employee Assistance Program (EAP)
• Commuter/Parking Accounts
• People Perks
• Health Savings Account (HSA)
• AD&D Insurance

If you have expertise in design assurance, quality engineering, DHF remediation, and medical electrical equipment, apply today for this exciting contract opportunity in Maple Grove, MN.

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