Senior Human Factors Engineer

Precision Neuroscience•Santa Clara, CA

3d•Onsite

About The Position

Precision Neuroscience is seeking a Senior Human Factors Engineer to own human factors and usability research for their Layer 7 platform. This role is crucial as the platform moves from early development into regulated device phases, including feasibility studies, clinical trials, and regulatory submission. The engineer will plan and conduct usability evaluations, contribute to risk analysis and task analysis, and collaborate with various teams (QA, Regulatory, Engineering, Design) to ensure user needs shape the device's development. This position is based in the Santa Clara office, and remote work is not an option. The company is a fast-moving, well-capitalized organization in the brain-computer interface field, founded in 2021 with significant funding and ongoing human trials.

Requirements

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.

Nice To Haves

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.

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.
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.