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.
The base pay range listed reflects what we reasonably expect to offer for this role. Actual pay may vary based on location, experience, and performance. Depending on the position, benefits may include medical, dental, and vision coverage; retirement and savings plans; paid holidays and time off; supplemental insurance; and additional wellness or incentive programs.
About UsAdvantage Technical connects top- talent in technology, engineering, and technical fields with forward-looking companies.
Advantage Technical is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Advantage Technical offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Advantage Technical is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.
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