Human Factors Engineering (HFE) Lead - Associate Engineering Fellow (AEF)
Core
Lead Human Centered Design for medical devices and combination products, advancing AI-enabled Human Factors Engineering capabilities.
Role type
Senior IC Human Factors Engineering Lead (Associate Engineering Fellow)
Builds
Medical device and combination product user interfaces (hardware, software, packaging, labeling, instructions)
Domain
Medical Devices / Biotechnology / Human Factors Engineering
Deliverable
production ML models
Required skills
Human Factors Engineering, User Research, AI-augmented research, predictive modeling, risk management, regulatory strategy, vendor management, usability engineering, cross-functional collaboration, mentoring
Preferred skills
Digital ethnography, remote usability platforms, synthetic user simulations, data-driven signal detection
Technologies
AI tools, remote usability platforms, synthetic user simulation tools
Responsibilities
Lead Human Factors strategy and User Research; Develop HFE requirements aligned with Target Product Profile; Conduct exploratory and AI-augmented research; Design and execute HFE studies; Perform use-safety engineering and risk management; Develop Validation Protocols and Usability Engineering Files; Manage HFE vendors; Create SOPs and templates; Partner with cross-functional teams; Mentor HFE Leads.
Seniority
Senior, hands-on IC with mentorship responsibilities