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Senior Human Factors Engineer

Precision· Product
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Santa Clara, CA$150k - $175kFull-timePosted 3w ago

About the role

Senior Human Factors Engineer to own usability research and HF activities for Layer 7 platform, guiding design through late-stage regulated device phases, clinical trials, and regulatory submission.

Responsibilities

  • Plan, conduct, analyze, and document formative usability evaluations to inform and iterate on product designs
  • Lead the planning and protocol development for summative (HF validation) testing; conduct and document testing as appropriate
  • Collaborate with QA, Regulatory, and engineering teams to inform and review use-related hazard and risk analyses (e.g., uFMEA)
  • Develop, maintain, and disseminate detailed task analyses for all clinical and user workflows
  • Collaborate with product designers to develop product labeling, Instructions for Use (IFU), and training materials
  • Lead end-to-end user research studies from study design and protocol development through execution, analysis, and reporting, translating findings into actionable product and business recommendations
  • Travel up to 10% for research activities
  • Ensure HF activities and documentation align with applicable standards and regulatory guidance (e.g., IEC 62366-1 and FDA human factors guidance) and support regulatory submissions

Qualifications

  • 3-6 years of human factors or usability research experience, including hands-on work in a regulated medical device environment
  • Bachelor's or Master's degree in Human Factors Engineering, Biomedical or Industrial Engineering, Human-Computer Interaction, Cognitive Science, or a related field
  • Demonstrated experience planning, moderating, and reporting formative and summative usability studies with clinical users
  • Experience running full-cycle human-subject research studies
  • Working knowledge of IEC 62366-1 and FDA human factors guidance, and a clear understanding of how HF evidence is assembled for a regulatory submission
  • Experience contributing to use-related risk analysis (uFMEA, use-error and critical-task analysis) alongside QA and Regulatory partners
  • Ability to produce and maintain task analyses, use specifications, and HF engineering reports to an audit-ready standard
  • Strong cross-functional collaborator, comfortable working alongside surgeons and clinical staff, hardware and software engineers, designers, and regulatory teams
  • Experience with neurotechnology a plus
  • Experience with novel, de novo, or implantable devices, or with early feasibility studies, is a strong plus; genuine curiosity about clinical workflows is essential

Skills

Required:Formative usability evaluationsSummative usability testing (HF validation)Use-related risk analysis (uFMEA)Task analysisInstructions for Use (IFU) and labelingUser research leadershipRegulatory knowledge (IEC 62366-1, FDA HF guidance)Cross-functional collaborationClinical workflow curiosity
Nice to have:Neurotechnology experience

Benefits

  • Competitive salary
  • Hybrid workplace in Santa Clara, CA
  • Medical, dental, vision, and life insurance
  • 401(k) with company match
  • Paid time off and holidays
  • Opportunity to work on cutting-edge brain–computer interface technology
Last updated Oct 21, 2026. Interested? Apply on the company site.

About Precision

The brain-computer interface that will change everything

Unlocking the full potential of the brain.

brain–computer interfaceneurotechnologyhealthcareneuroscience
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