Design Quality Engineer

RQM+ is The Med Tech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients — faster, safer, better.

We don’t make Med Tech. We make Med Tech happen.

Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the Med Tech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency.

Must be local to Arbor Lakes Minnesota (near Maple Grove)

Job Summary:

The Design Quality Engineer (DQA) will serve as the quality representative for product development and remediation activities, partnering closely with R&D to ensure robust application of design controls and risk management throughout the product lifecycle.

This role has primary responsibility for design risk management activities, oversight of design verification and validation execution, and approval of all R&D-driven updates to the Design History File (DHF). The DQA will ensure design outputs, testing, and risk controls meet FDA and ISO regulatory expectations and are inspection-ready.

Primary Responsibilities:

Design Controls & Quality Oversight

• Act as the Design Quality representative on R&D projects, ensuring compliance with FDA Design Controls (21 CFR 820) and ISO 13485.
• Review and approve all R&D changes to the Design History File (DHF).
• Ensure traceability between user needs, design inputs, risk controls, verification, and validation.
• Lead and maintain design risk management activities in accordance with ISO 14971.
• Develop, update, and approve:
• Design FMEAs (DFMEAs)
• Task Analyses
• Ensure risk controls are appropriately implemented, verified, and validated.
• Assess residual risk acceptability and ensure proper benefit-risk justification.

Verification, Validation & Human Factors

• Partner with R&D to plan, review, and approve design verification activities, including test protocols and reports.
• Partner with R&D to plan, review, and approve design validation activities, ensuring alignment with intended use and user needs.
• Support and approve human use / human factors activities, including usability engineering documentation.
• Ensure design validation includes appropriate clinical or simulated use considerations where applicable.

Cross-Functional Collaboration

• Work closely with R&D, Regulatory Affairs, Clinical, and Manufacturing teams to resolve quality and compliance issues.
• Provide guidance on regulatory expectations related to design changes, risk controls, and testing strategies.
• Support internal and external audits, regulatory inspections, and responses to findings.

Behaviors: Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning

Requirements:

• Bachelor’s degree in Engineering, Biomedical Engineering, or a related technical discipline.
• 5–8+ years of experience in medical device quality or design engineering.
• Strong hands-on experience with design controls and design risk management.
• Demonstrated experience creating and maintaining:
• DFMEAs
• Hazard analyses
• Task analyses
• Experience supporting and approving design verification and validation activities.
• Working knowledge of ISO 14971, 21 CFR 820, and ISO 13485.
• Ability to independently review and approve DHF documentation.
• Strong written and verbal communication skills.

Work Environment/Physical Demands: This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers and filing cabinets. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions…