Senior Human Factors Engineer: Medical Device Usability

Precision Neuroscience; Santa Clara (CA); Presencial; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

Precision Neuroscience seeks a Senior Human Factors Engineer in Santa Clara, CA to own usability research for our Layer 7 platform as it moves toward late-stage development and regulatory submission.

You will plan formative and summative usability evaluations, contribute to use-related risk analyses, and partner with QA, Regulatory, Engineering, and Design to ensure clinician and patient workflows shape the device.

Formación

• 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.
• Experience running full-cycle human-subject research studies.
• Knowledge of IEC 62366-1 and FDA human factors guidance for regulatory submissions.
• Experience contributing to use-related risk analyses (uFMEA).
• Ability to produce task analyses and HF engineering reports for audit-ready documentation.
• Strong collaboration with surgeons, clinicians, hardware/software engineers, and regulatory teams.
• Experience with neurotechnology or implantable devices is a plus.

Responsabilidades

• Plan, conduct, analyze, and document formative usability evaluations to inform product designs.
• Lead planning and protocol for summative HF testing and document results.
• Collaborate with QA, Regulatory, and engineering to review use-related hazard analyses.
• Develop and maintain detailed task analyses for clinical and user workflows.
• Collaborate on product labeling, IFU, and training materials.
• Lead end-to-end user research studies from design to reporting with actionable recommendations.
• Travel up to 10% for research activities.
• Ensure HF activities align with IEC 62366-1 and FDA guidance and support regulatory submissions.

Conocimientos

Usability research

Formative studies

Summative testing

uFMEA

IEC 62366-1

FDA HF guidance

Cross-functional

Task analyses

Educación

Bachelor's or Master's degree in Human Factors Engineering / Biomedical / Industrial Engineering / HCI

Descripción del empleo

Precision Neuroscience seeks a Senior Human Factors Engineer in Santa Clara, CA to own usability research for our Layer 7 platform as it moves toward late-stage development and regulatory submission.

You will plan formative and summative usability evaluations, contribute to use-related risk analyses, and partner with QA, Regulatory, Engineering, and Design to ensure clinician and patient workflows shape the device.