Lead the integration of human factors engineering and usability strategies for medical devices, combination products, and healthcare technologies
Collaborate with cross-functional teams across Design, Engineering, Regulatory Affairs, Quality, and Clinical to embed human factors principles throughout the product lifecycle
Drive global strategies, support regulatory submissions, and mentor junior staff
Develop and implement global human factors strategies for product design and development
Identify critical user interactions, use environments, and potential risks impacting safety and efficacy
Integrate human factors early in the design process to minimize risk and optimize usability
Guide interface design, labeling, and user instructions to improve user experience
Conduct human factors risk assessments in alignment with ISO 14971 and company risk management procedures
Plan and execute formative and summative usability studies
Analyze study data to identify usability issues and recommend design modifications
Document human factors and usability validation activities for regulatory submissions
Partner with Clinical, Regulatory, Quality, and Manufacturing teams to ensure integrated design development
Participate in project planning, milestone reviews, and senior leadership meetings.

Master’s or PhD in Human Factors, Industrial Design, Human-Computer Interaction, Ergonomics, Biomedical Engineering, or a related field
8–12 years of experience in human factors engineering, usability, or related product development
Experience in medical devices, combination products, or healthcare technologies
Proven experience conducting formative and summative usability studies
Knowledge of human factors standards (IEC 62366, FDA guidance, ISO 14971)
Expertise in human factors and usability engineering
Strong understanding of design controls and risk management
Experience with usability study design, execution, and analysis
Regulatory knowledge for HF submissions and compliance
Cross-functional collaboration and project leadership
Excellent written and verbal communication skills.

Associate Director, Human Factors Design – Development

Key skills