Senior Human Factors & Usability Engineer; Medical Devices

Location:

Tucson (On-site). Might require occasional travel to Santa Clara, Pleasanton, or Tucson.

Employment Type: Contract (W2 or C2C).

Duration: 12 months. Possibility of renewal depending on personal performance and business needs.

Rate: $ / hr - $65.

Requirements: must be authorized to work legally in the US without sponsorship now or in the future.

Concord isnt your typical consulting firm; we are an execution company with a passion for making things happen. Our mission is to help clients enhance customer experiences, optimize operations, and revolutionize their product offerings through seamless integration, optimization, and activation of technology and data.

We are purpose-built merging the industry’s top specialty companies to amplify our Innovation Capabilities in analytics & AI, data management & engineering, UX and digital experience, and technical platform integration, automation & security engineering.

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 wont 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 58 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…