Senior Human Factors Engineer - Medical Device Usability

Socket.dev; Santa Clara (CA); On-site; USD 120,000 - 190,000; Full time

Job summary

Precision Neuroscience in Santa Clara is seeking a Senior Human Factors Engineer to lead usability research for Layer 7 as it advances through late-stage development toward regulatory submission.

You will design and run formative and summative evaluations, build use-related risk analyses, and partner with QA, Regulatory, Engineering, and Design to ensure clinicians and patients use the device as intended.

Qualifications

• 3–6 years of human factors or usability research experience in a regulated medical device environment.
• Bachelor's or Master's degree in Human Factors Engineering, Biomedical or Industrial Engineering, HCI, Cognitive Science, or related field.
• Experience planning, moderating, and reporting formative and summative usability studies with clinical users.
• Experience running full-cycle human-subject research studies.
• Strong knowledge of IEC 62366-1 and FDA human factors guidance for regulatory submissions.
• Experience contributing to use-related risk analyses (uFMEA, use-error and critical-task analysis).
• Ability to produce and maintain task analyses, use specifications, and HF engineering reports to an audit-ready standard.
• Strong cross-functional collaboration with surgeons, clinicians, hardware/software engineers, designers, regulators.

Responsibilities

• Plan, conduct, analyze, and document formative usability evaluations to inform product designs.
• Lead planning and protocol development for summative HF testing and conduct tests.
• Collaborate with QA, Regulatory, and engineering on use-related hazard and risk analyses (e.g., uFMEA).
• Develop, maintain, and disseminate detailed task analyses for clinical and user workflows.
• Collaborate with product designers on labeling, IFU, and training materials.
• Lead end-to-end user research studies from design to reporting and translate findings into actionable recommendations.
• Travel up to 10% for research activities.
• Ensure HF activities align with regulatory guidance and support submissions.

Skills

Human factors

Usability research

Regulated medical device

Clinical collaboration

Education

Bachelor's or Master's in Human Factors/engineering

Tools

IEC 62366-1

FDA human factors guidance

Job description

Precision Neuroscience in Santa Clara is seeking a Senior Human Factors Engineer to lead usability research for Layer 7 as it advances through late-stage development toward regulatory submission.

You will design and run formative and summative evaluations, build use-related risk analyses, and partner with QA, Regulatory, Engineering, and Design to ensure clinicians and patients use the device as intended.