Senior Human Factors Engineer

Neara; Santa Clara (CA); Hybrid; 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

ABOUT PRECISION NEUROSCIENCE

Precision Neuroscience is building a next-generation brain–computer interface (BCI) to heal and empower millions of people living with neurological conditions.

Our first product, Layer 7, is designed to help people with severe paralysis operate digital devices using only their thoughts—opening up new possibilities for daily life.

Our team brings together experts in neurosurgery, AI and machine learning, microfabrication, electrical engineering, clinical science, and more. We combine deep technical rigor with a people-first mindset to turn breakthrough research into real-world medical solutions.

As a Precision employee, you’ll join one of the fastest-moving and best-capitalized companies in the emerging field of brain–computer interfaces. Since our founding in 2021, we have raised more than $180 million, advanced our technology through validation, and initiated human trials with leading hospitals across the country.

Our Values:

build for human impact, measuring progress by the lives our work can change.

do no harm, holding ourselves to the highest standards of safety, integrity, and responsibility.

innovate with urgency because the stakes are high and our users can’t wait.

bring sharp minds, open ears, pairing expertise with curiosity, humility, and respect.

lead the way, taking ownership of our work and helping to shape the future of our field.

We are 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 partner closely with QA, Regulatory, Engineering, and Design to ensure the way clinicians and patients actually use our device shapes how it is built.

This position will be based in our Santa Clara office. We are unable to consider remote workers or individuals who are not currently based in the US and not legally authorized to work in the US.

Key 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


• Ability to 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

Skills, Knowledge and Expertise

• 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

Diverse workforces create the best culture, company, and products. We at Precision are committed to an inclusive culture that celebrates the uniqueness and contributions of everyone.

As an equal opportunity employer, Precision does not discriminate on the basis of sex, race, religion, national origin, disability status, protected veteran status, or any other characteristic protected by law.

The actual base salary offered is determined by a number of variables, including, as appropriate, the applicant's qualifications for the position, years of relevant experience, distinctive skills, level of education attained, certifications or other professional licenses held, and the location of residence and/or place of employment.

For roles based in Massachusetts it is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.