Principal Human Factors Engineer
Core
Lead strategic integration of human-centered design for physician-facing medical technologies and patient-facing regulated consumer health solutions to ensure clinical safety and usability.
Role type
Principal Human Factors Engineer (Strategic IC)
Builds
Physician and patient-facing medical devices and digital health solutions
Domain
Healthcare / Medical Devices / Digital Health
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Usability engineering, risk-informed design, human-centered innovation, FDA Human Factors Guidance, IEC 62366-1, ISO 14971, AAMI HE75, TIR 50, usability validation strategies, use-related risk analysis, regulatory documentation authoring, mixed-method user research, contextual inquiry, simulation-based testing, workflow modeling, cognitive load analysis, qualitative and quantitative research synthesis
Preferred skills
Decision-support systems design, AI-enabled health tools, connected health devices, software as a medical device (SaMD), digital therapeutics, wearable technologies, global regulatory environments (EU MDR, Health Canada), advanced degree in Human Factors
Technologies
FDA Human Factors Guidance, IEC 62366-1, IEC 62366-2, ISO 14971, AAMI HE75, TIR 50
Responsibilities
Define and drive human factors vision and strategy across product portfolios; lead human factors activities in compliance with regulatory standards; design and conduct usability studies with physicians, patients, and caregivers; model and optimize end-to-end clinical and home workflows; mentor teams on human-centered design and usability risk mitigation; introduce advanced methods like AI-assisted research and real-world evidence analysis
Seniority
Principal, hands-on IC with strategic influence
