
Senior Human Factors Engineering Consultant
Concord
contract
Posted on:
Location Type: Remote
Location: Remote • Arizona • 🇺🇸 United States
Visit company websiteSalary
💰 $60 - $70 per hour
Job Level
Senior
About the role
- Lead Human Factors Strategy & Execution: Own the usability engineering roadmap across the product lifecycle, from early discovery to market release.
- Anticipate user needs, risks, and system-level implications before issues arise.
- Define the vision, strategy, and priorities for human factors activities and communicate them across cross-functional teams.
- Usability Engineering & Design Controls: Lead the creation and maintenance of Usability Engineering Files in accordance with IEC 62366 and FDA Human Factors guidance.
- Identify user profiles, tasks, critical use scenarios, usability risks, and system requirements.
- Translate user needs, UX research insights, clinical workflows, and business needs into actionable HFE requirements.
- User Research & Study Leadership: Independently plan, design, and execute formative and summative usability studies (hardware, software, or integrated systems).
- Manage external vendors and ensure high-quality execution, documentation, and data integrity.
- Analyze behavioral and physiological data to uncover deep insights that drive product decisions.
- Cross-Functional Collaboration & Influence: Champion usability, safety, accessibility, and quality across R&D, Engineering, UX, Clinical, Regulatory, and Marketing.
- Facilitate workshops with customers, clinical partners, and internal teams to capture system-level insights and drive alignment.
- Proactively identify gaps, propose solutions, and push initiatives forward with minimal supervision.
- Thought Leadership & Mentorship: Serve as a subject matter expert for Human Factors Engineering within the organization.
- Mentor and guide junior team members on methodology, study design, analysis, and professional development.
- Present insights and recommendations persuasively to technical and non-technical audiences, including leadership.
Requirements
- 10+ years of applied Human Factors Engineering experience in the medical device or healthcare technology industry.
- Demonstrated ability to own the Human Factors Engineering strategy on complex products, anticipating challenges, proposing solutions, and driving execution.
- Deep knowledge of IEC 62366, FDA HFE guidance, risk management (ISO 14971), and Design Controls.
- Strong experience with digital product usability (software, apps, integrated systems).
- Proven experience planning, conducting, and documenting both formative and summative usability studies.
- Ability to manage multiple projects simultaneously, prioritize effectively, and maintain timelines.
- Skills in stakeholder coordination and vendor management for usability studies.
- Experience developing training materials and improving related workflows.
- Familiarity with UX research or interaction design methods and the ability to influence early-stage design.
- Strong workshop facilitation skills and experience collaborating with customers, clinicians, and multi-disciplinary teams.
- Exceptional verbal and written communication skills.
- A proactive mindset with the ability to work autonomously, handle ambiguity, and deliver high-quality outcomes.
- An advanced degree in Human Factors, Cognitive Psychology, Biomedical Engineering, or related fields is a plus.
- Experience with diagnostic devices, point-of-care systems, or integrated hardware–software medical products.
Benefits
- Health, Dental, and Vision Insurance - Comprehensive coverage to support your overall well-being.
- Employer Contributions to Health Savings Accounts (HSA) - For employees enrolled in High Deductible Health Plans, Concord contributes toward your HSA.
- Flexible Spending Accounts (FSA) - Options for healthcare and dependent care expenses, plus a Lifestyle Spending Account (LSA) for wellness and personal development.
- Disability Insurance - Short-term (up to 12 weeks) and long-term coverage, fully paid by the employer.
- Life and AD&D Insurance - Employer-provided coverage of with options for additional voluntary coverage.
- Employee Assistance Program (EAP) - Support for legal, financial, and personal challenges.
- 401(k) Retirement Savings - 1% employer match.
- Career Growth Opportunities - Pathways for advancement and skill development.
- Team Engagement Activities - Regular team-building events and company-sponsored activities to foster collaboration and connection.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Human Factors EngineeringUsability EngineeringUsability StudiesIEC 62366FDA HFE guidanceISO 14971Digital Product UsabilityRisk ManagementStudy DesignData Analysis
Soft skills
Cross-Functional CollaborationStakeholder CoordinationWorkshop FacilitationMentorshipCommunicationProactive MindsetProject ManagementProblem SolvingInfluencing SkillsAutonomy