Human Factors Engineer

RQM+; North Carolina; Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Industry leading compensation package

Investment in ongoing learning and development

Work-life balance initiatives

Job summary

A leading MedTech CRO is seeking an experienced Human Factors professional to enhance product usability and safety within regulated medical environments. The ideal candidate possesses at least 10 years of relevant experience and a bachelor's degree. Responsibilities include planning usability studies, collaborating across teams, and ensuring compliance with FDA and IEC standards. This role offers a hybrid work environment, enabling flexibility with travel for onsite engagements as needed.

Qualifications

• Minimum 10 years of hands‑on human factors/usability experience in regulated medical device environments.
• Proven knowledge of FDA, IEC, and ISO standards.

Responsibilities

• Plan and implement human factors activities across development stages.
• Design and execute usability studies with detailed reports.
• Analyze user needs and drive risk analysis.

Skills

Usability testing methodologies

Documentation skills

Facilitation and interviewing

Analytical mindset

Cross‑functional collaboration

Effective communication

Self‑motivated

Education

Bachelor’s degree in relevant field

Job description

RQM+ is The MedTech 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 MedTech. We make MedTech 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 MedTech 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.

Location: Charlotte, NC or Cary, NC or remote if open to traveling 50% Likely two, 2-week trips to be on-site

Duration: 8-10 weeks

Key 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

Qualifications

Education & Experience

• 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

Skills & Attributes

• 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

Behaviors

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

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 of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift or move objects up to 10 pounds and occasionally lift or move objects up to 25 pounds.

Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today!

We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.

Job Opportunity Verification

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