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RQM+ · 4 days ago

Human Factors Engineer

United States

Full-time

Onsite

Senior Level, Lead/Staff

10+ years exp

RQM+ is a MedTech CRO that accelerates innovation to patient impact through regulatory and quality expertise. The Human Factors Engineer will plan and implement human factors activities, develop usability documentation, and collaborate with various teams to ensure compliance and optimize product interfaces.

Health CareMedicalMedical Device

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

Human Factors EngineeringUsability Testing MethodologiesFDA Regulations KnowledgeCognitive PsychologyCross-Functional CollaborationAnalytical MindsetDocumentation SkillsEffective CommunicationSelf-Motivated

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

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