RQM+ · 23 hours ago
Design Quality Engineer
Maple Grove, MN
Contract
Onsite
Senior Level
5+ years expRQM+ is a MedTech CRO focused on accelerating innovation to patient impact. The Design Quality Engineer will serve as the quality representative for product development and remediation activities, ensuring compliance with design controls and risk management throughout the product lifecycle.
Health CareMedicalMedical Device
Hiring Manager
Jessica Miller
Responsibilities
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), Hazard Analyses, Task Analyses
Ensure risk controls are appropriately implemented, verified, and validated
Assess residual risk acceptability and ensure proper benefit-risk justification
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
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
Qualification
Required
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
Benefits
Industry leading compensation package
Deeply engrained focus on work life balance
Company
RQM+
RQM+ is a medical device company providing medical device and post-market surveillance services.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Linden Capital Partners
2021-08-16Private Equity
Leadership Team
John Potthoff
Chief Executive Officer
Recent News
2026-01-09
SS Innovations
2025-10-03
2025-09-23
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