RQM+ · 1 day ago
Human Factors Engineer
North Carolina, United States
Contract
Hybrid
Senior Level, Lead/Staff
10+ years expRQM+ is a MedTech CRO focused on accelerating innovation to patient impact. The Human Factors Engineer will plan and implement human factors activities across various stages of product development, collaborate with cross-functional teams, and lead usability studies to ensure compliance with regulatory standards.
Health CareMedicalMedical Device
Hiring Manager
Jessica Miller
Responsibilities
Plan & implement human factors activities across concept, development, validation, and post-market stages
Develop and maintain usability documentation: Use Specs, Task Analyses, uFMEA, Usability Plans, UEFs/UEFs
Design, author, and execute formative and summative usability studies, including protocols, surveys, moderator guides, scenarios, and detailed reports
Conduct user research: contextual inquiries, heuristic evaluations, interviews; distill insights to inform design, identify user needs, and drive use-related risk analysis
Collaborate closely with R&D, design, labeling, packaging, and quality teams to advise on human factors compliance and optimize product interfaces
Identify and assess use-related hazards; incorporate risk control recommendations into design and usability validation
Lead simulated use (Design Validation) studies to demonstrate safety and effectiveness per IEC 62366 and FDA guidance
Qualification
Required
Bachelor's degree in Human Factors, Human‑Computer Interaction, Cognitive Psychology, Biomedical Engineering, Industrial Engineering, or similar
Minimum 10 years of hands-on human factors/usability experience in regulated medical device environments
Proven knowledge of FDA (21 CFR 820, Human Factors Guidance), IEC 62366‑1, ISO‑14971, AAMI HE75 standards
Expertise in usability testing methodologies and HF engineering principles
Strong documentation skills—able to prepare detailed protocols, HF files, plans, and reports
Excellent facilitation, interviewing, and observational capabilities
Analytical mindset with the ability to tie test evidence to risk mitigation strategies
Demonstrated experience in cross-functional collaboration
Effective written and oral communication
Self-motivated, proactive, and able to work both independently and in team settings
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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