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 products are safe, effective, and user-friendly.
Role type
Senior leadership human factors engineering director
Builds
Medical devices, combination products, and healthcare technologies
Domain
Healthcare / Medical Devices
Required skills
Human factors engineering, Usability engineering, Risk management (ISO 14971), Regulatory compliance (FDA, EU MDR), Usability study design and execution, Design controls, Cross-functional leadership, Strategic planning
Preferred skills
Master's or PhD in Human Factors, Industrial Design, HCI, Ergonomics, or Biomedical Engineering
Technologies
IEC 62366, FDA guidance, ISO 14971
Responsibilities
Develop and implement global human factors strategies, Lead human factors design inputs and design controls, Conduct human factors risk assessments, Plan and execute formative and summative usability studies, Support preparation of HF-related sections of regulatory submissions, Mentor junior HF staff
Seniority
Senior, hands-on IC with leadership responsibilities