Senior Human Factors Engineer, Medical Device Usability Lead

Neara; Santa Clara (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Precision Neuroscience is seeking a Senior Human Factors Engineer to own human factors and usability research for our Layer 7 platform as it advances beyond early development into late-stage regulated device phases, through early feasibility studies and clinical trials, toward an eventual regulatory submission.

In this role, you will plan and run formative and summative usability evaluations, contribute to the use‑related risk and task analysis foundation that underpins our submission, and

Qualifications

• 3–6 years of human factors or usability research in a regulated medical device environment.
• Experience planning, moderating, and reporting formative and summative usability studies with clinical users.
• Working knowledge of IEC 62366-1 and FDA human factors guidance, and how HF evidence is assembled for regulatory submissions.
• Ability to produce audit-ready HF engineering reports and documentation.
• Strong cross‑functional collaboration with surgeons, engineers, designers, QA and Regulatory.

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 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.
• Ability to travel up to 10% for research activities.
• Ensure HF activities and documentation align with applicable standards and regulatory guidance (IEC 62366-1 and FDA HF guidance) and support regulatory submissions.

Skills

HF research

Usability testing

Regulated medical device

Cross-functional collaboration

Analytical thinking

Education

Bachelor's or Master's in Human Factors Engineering or related field

Job description

Precision Neuroscience is seeking a Senior Human Factors Engineer to own human factors and usability research for our Layer 7 platform as it advances beyond early development into late-stage regulated device phases, through early feasibility studies and clinical trials, toward an eventual regulatory submission.

In this role, you will plan and run formative and summative usability evaluations, contribute to the use‑related risk and task analysis foundation that underpins our submission, and