Associate Director, Human Factors Design and Development

Job summary

The Associate Director of Human Factors Design and Development will lead the integration of human factors engineering and usability strategies for medical devices and healthcare technologies, ensuring products are safe, effective, and user-friendly. This role involves collaboration with cross-functional teams to embed human factors principles throughout the product lifecycle, drive global strategies, support regulatory submissions, and mentor junior staff.

Qualifications

• 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).
• Strong understanding of design controls and risk management.
• Excellent written and verbal communication skills.

Responsibilities

• 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.
• Lead human factors design inputs, design controls, and usability engineering throughout the product lifecycle.
• Conduct human factors risk assessments and execute usability studies.
• Support preparation of HF-related sections of regulatory submissions and ensure compliance with international standards.
• Mentor and develop junior HF staff and participate in project planning and milestone reviews.

Skills

• Expertise in human factors and usability engineering.
• Experience with usability study design, execution, and analysis.
• Cross-functional collaboration and project leadership skills.

Education

• Advanced degree in relevant fields such as Human Factors or Biomedical Engineering.

Tools

• Familiarity with human factors standards and regulatory requirements for medical devices.