Senior Human Factors & Usability Engineer (Medical Devices)

Concord USA • Tucson, AZ

32d • $50 - $65 • Onsite

About The Position

We are seeking a Senior Human Factors & Usability Engineer who combines deep expertise in medical device usability with an entrepreneurial, ownership-driven mindset. You will play a critical role in shaping the next generation of diagnostic medical devices—leading human factors strategy, anticipating user risks and needs, and driving solutions from concept through verification. As a senior member of the team, you won’t just execute studieS, you will own the usability engineering vision, identify what needs to happen before being asked, and translate complex insights into clear recommendations that influence product, engineering, and leadership teams. This role is ideal for someone who thrives in ambiguity, moves quickly from insight to action, and takes full responsibility for outcomes.

Requirements

• 5–8+ years of applied Human Factors Engineering experience in the medical device or healthcare technology industry.
• Demonstrated ability to own the HFE strategy on complex products, anticipating challenges, proposing solutions, and driving execution.
• Deep knowledge of IEC 62366, FDA HFE guidance, Design Controls, and risk management (ISO 14971).
• Proven experience planning, conducting, and documenting both formative and summative usability studies.
• Experience synthesizing behavioral, physiological, and qualitative data into actionable design recommendations.
• Familiarity with UX research or interaction design methods.
• 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.

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• Health, Dental, and Vision Insurance: Comprehensive coverage to support your well-being.
• Employer Contributions to Health Savings Accounts (HSA): Helping you save for medical expenses.
• Flexible Spending Accounts (FSA): Options for healthcare and dependent care expenses, plus a $200 Lifestyle Spending Account (LSA).
• Disability Insurance: Short- and long-term coverage, fully paid by the employer.
• Life and AD&D Insurance: Employer-provided coverage, with options for additional voluntary coverage.
• Employee Assistance Program (EAP): Access to personal and professional support resources.
• 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.

What This Job Offers

• Career Level: Senior
• Number of Employees: 51-100 employees