Associate Director, Human Factors Engineering
Core
Lead the integration of human factors engineering and usability strategies for medical devices, combination products, and healthcare technologies to ensure product safety, effectiveness, and user-friendliness.
Role type
Senior IC human factors engineering director (medical devices)
Builds
Medical devices, combination products, and healthcare technologies
Domain
Healthcare / Medical Devices
Required skills
Human factors engineering, Usability engineering, Risk assessment (ISO 14971), Regulatory compliance (FDA, EU MDR), Usability study design and execution, Design controls, Cross-functional leadership, Project management
Preferred skills
Master's or PhD in Human Factors/Industrial Design/HCI/Ergonomics/Biomedical Engineering, Experience with IEC 62366, Mentorship of junior staff
Technologies
ISO 14971, IEC 62366, FDA guidance, EU MDR
Responsibilities
Develop and implement global human factors strategies, Conduct human factors risk assessments, Plan and execute formative and summative usability studies, Support preparation of HF-related sections of regulatory submissions, Mentor and develop junior HF staff, Partner with Clinical, Regulatory, Quality, and Manufacturing teams
Seniority
Senior, hands-on IC with mentorship responsibilities