Human Factors Engineering (HFE) Lead - Associate Engineering Fellow (AEF)
Core
Lead Human Factors Engineering (HFE) for medical devices and combination products, driving user-centered design, AI-enabled research, and regulatory compliance to ensure safe and effective product use.
Role type
Senior IC Human Factors Engineering Lead (Associate Engineering Fellow)
Builds
Medical device and combination product user interfaces (hardware, software, packaging, labeling) and AI-enabled HFE capabilities
Domain
Medical Devices / Biotechnology / Human Factors Engineering
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Human Factors Engineering strategy, User Research strategy, regulatory compliance (IEC/ISO), risk management, predictive modeling, AI-assisted signal detection, vendor management, usability engineering file development, cross-functional partnership, mentoring
Preferred skills
Digital ethnography, remote usability platforms, synthetic user simulations, data-driven risk management, design controls
Technologies
AI tools, remote usability platforms, synthetic user simulation tools
Responsibilities
Lead and execute Human Factors strategy; Drive User Research strategy; Develop HFE product and system requirements; Conduct exploratory and AI-augmented research; Translate user needs into UX requirements; Design and execute HFE studies; Perform use-safety engineering and risk management; Develop HFE validation protocols and reports; Manage HFE vendors; Create regulatory strategies; Develop Usability Engineering Files; Lead SOP development; Partner with cross-functional teams; Support quality audits; Mentor HFE Leads
Seniority
Senior, hands-on IC with mentorship responsibilities
