Design Quality Engineer - Hybrid | Maple Grove, MNPay Rate: $43.04-$54.95 per hour
Location: Maple Grove, MN (Hybrid - Arbor Lakes Campus)
Shift: Business Hours
We are seeking a highly collaborative
Design Quality Engineer to support design assurance, risk management, and quality system activities for a commercialized medical device. This is an excellent opportunity for an experienced engineer with a strong background in
design controls, quality systems, risk analysis, verification and validation, and regulatory compliance.
Key Responsibilities
- Review, update, and maintain design control documentation and Design History Files (DHF)
- Support verification and validation activities, including evaluation of testing requirements and documentation updates
- Manage risk management documentation, including FMEA, Hazard Analysis, and Fault Tree Analysis
- Partner with cross-functional teams to implement quality improvements and maintain product compliance
- Support usability documentation, assessments, and related deliverables
- Participate in design change activities, ensuring compliance with quality and design control processes
- Apply structured problem-solving methods to investigate and resolve quality issues
Qualifications
- Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or related field
- 4+ years of engineering experience in a regulated industry
- Strong understanding of quality systems, design controls, risk management, and product lifecycle processes
- Proven communication, collaboration, and organizational skills
- Ability to work effectively in a hybrid team environment
- Self-motivated with a hands-on approach to problem-solving
Additional Information
- Local candidates preferred
- Hybrid work schedule based in Maple Grove, MN
- Multiple video interview rounds may be required
- Applicants must be authorized to work in the U.S. without current or future visa sponsorship
Benefits
- Medical, dental, vision, and pet insurance
- 401(k) Retirement Savings Plans
- Employee Assistance Program (EAP)
- Commuter/Parking Accounts
- People Perks
- Health Savings Account (HSA)
- AD&D Insurance
If you're an experienced Quality Engineer looking to make an impact in medical device design assurance and compliance,
click "Apply Now" today.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.
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