Human Factors and Usability Engineering Director
Core
Lead complex Human Factors and Usability Engineering (HF/UE) programs for drug delivery devices (Insulin Pens, Autoinjectors, etc.) across the full product lifecycle, ensuring regulatory compliance and user-centered design.
Role type
Senior individual contributor Director of Human Factors and Usability Engineering
Builds
Regulatory-compliant HF/UE solutions and documentation for combination products (drug-device)
Domain
Biopharma / Medical Devices / Human Factors Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Human Factors Engineering, Usability Engineering, Combination Product Development, Regulatory Submissions (FDA/EMA), Risk Analysis (URRA), Study Design (Generative/Formative/Summative), Cross-functional Influence, Mentoring
Preferred skills
Parenteral Delivery Systems, SaMD, Digital Health, AI/ML in Medical Devices, Portfolio-level Strategy, Broad Therapeutic Area Experience
Technologies
FDA HF Guidance, IEC 62366-1, ISO 14971, ISO 13485, HE75
Responsibilities
Lead high-stakes HF/UE programs with minimal oversight; Drive full HF/UE lifecycle from user needs to regulatory submission; Shape HF/UE strategy and roadmap; Lead external health authority engagement; Establish and improve HF/UE processes and standards; Influence cross-functional teams to embed user-centered design; Mentor HF/UE professionals
Seniority
Director, Senior Individual Contributor
