Human Factors Design Engineer
Core
Lead Human Factors (HF) efforts for new and sustaining medical device product development, ensuring products are feasible, viable, and desirable through user research, task analysis, and usability validation.
Role type
Senior Human Factors Design Engineer (HF Lead)
Builds
Medical devices (surgical systems) for clinical caregivers
Domain
Medical device industry + Human Factors/Usability Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
User-centered design, usability engineering, task analysis, usability risk analysis, formative and summative usability testing, regulatory submission documentation, root cause analysis, workflow design, international stakeholder engagement
Preferred skills
Medical device industry experience, design engineering in product development, empathy for human condition
Technologies
IEC 62366, AAMI HE75, FDA Human Factors guidelines
Responsibilities
Conduct user research (interviews, observations, simulations) to understand user needs and environments; Translate user needs into usability requirements and design inputs; Execute usability evaluations from explorative co-creation to formal validation; Author usability engineering documentation for regulatory submission; Analyze on-market complaints and update risk assessments; Collaborate with cross-functional teams (design, clinical, regulatory) to de-risk design strategies.
Seniority
Senior, hands-on IC with leadership responsibilities
