Senior Human Factors Engineer
About The Position
The Senior Human Factors Engineer works with designers, clinical engineers, and technical product managers to guide development of new products and ensure they are safe and easy to use. The role conducts user research, analyzes and characterizes use-related risks, and tests product usability before launch. It has primary responsibility for usability risk analyses and final usability validation studies, and collaborates with regulatory teams to prepare usability engineering documentation for medical device regulatory submissions. The engineer represents the Human Factors function on project teams, coordinates human factors work across projects and subsystems, and manages usability engineering activities and schedules. The role also promotes human-centered design across the organization, mentors junior colleagues, and advises management on relevant regulations, best practices, and potential process improvements. The position is onsite weekly, with the percentage of onsite work determined by the leader, and may require up to 25% domestic and international travel.
Requirements
- Bachelor’s degree in Human Factors Engineering, Cognitive Psychology, Computer Science with an HCI emphasis, Human Centered Design, or a related field.
- At least 8 years of relevant Human Factors or Usability Engineering experience in the hardware product development industry.
- Ability to lead usability engineering activities for complex, software-controlled electromechanical medical devices, including establishing usability requirements and creating risk analyses, test protocols, and test reports.
- Ability to interact with customers in a highly professional manner.
- Ability to analyze and synthesize large quantities of information into usable communications.
- Strong ability to write accurate, clear, and concise protocols, reports, and operating procedures in a timely manner.
- Excellent verbal communication and presentation skills.
- Ability to collaborate across organizational groups and management levels, including engineering, marketing, clinical engineering, and regulatory teams.
- Ability to apply user-centered design and usability engineering principles to product research, development, and design.
- Ability to travel domestically and internationally up to 25%.
Nice To Haves
- Master’s degree; strongly preferred.
- Experience in the medical-device industry or a similar regulated industry is a significant plus.
Responsibilities
- Collect and synthesize information about how users interact with products through interviews, simulations, direct observations, task analyses, and persona development.
- Present findings from field observations, research, and usability testing.
- Contribute to user-interface designs by recommending design changes to mitigate use errors and improve usability; assist with creating and revising user-interface requirements documents.
- Analyze complaints about products on the market, update usability risk assessments, and escalate usability-related issues as needed.
- Design, execute, and report usability tests throughout product development, from early prototypes through formal FDA-mandated validation testing.
- Write and execute usability test protocols, analyze test data, and write test reports.
- Develop validation strategies for projects that update existing products.
- Lead creation and updates of usability risk analyses for products.
- Maintain traceability among use risks, mitigations, and validation test cases.
- Promote a human-centered design approach across the organization.
- Represent the Human Factors function on core teams for large projects.
- Coordinate human factors activities across projects involving multiple subsystems.
- Manage usability engineering activities within development projects and provide schedules and status updates to technical product managers and engineering project managers.
- Mentor junior human factors engineers and others in usability engineering methods, best practices, and product development processes.
- Prepare and review documentation for regulatory agency and notified body submissions.
- Respond to questions and provide supporting justification and rationale.
- Track medical-device human factors regulations and best practices, including IEC 62366, AAMI HE75, and FDA guidance, and advise management on process improvements and regulatory issues related to usability engineering.
Benefits
- Market-competitive compensation package including base pay, incentives, benefits, and equity.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
