Responsibilities
- Lead human factors activities across the product lifecycle, from user research to post-launch analysis
- Translate user needs into actionable design requirements and interface concepts
- Plan and conduct representative user formative evaluations of product concepts, analyze data, document evaluation methods
- Ensure compliance with FDA Human Factors Guidance and IEC usability standards
- Collaborate with cross-functional teams including engineering, clinical, regulatory, and design
- Mentor team members and promote best practices in human factors engineering
- Maintain technical knowledge current with advancing technology related to Human Factors and medical devices (e.g., FDA & AAMI guidance and resources)
- Deliver clear, data-driven reports and risk-based design mitigation solutions to project teams
Requirements
- Bachelor’s degree in Human Factors, Usability Engineering, Cognitive/Experimental Psychology, Biomedical Engineering, Industrial Engineering, Cognitive Engineering, or related field
- Minimum 4 years of experience in human factors engineering or usability evaluation
- Demonstrated experience applying human factors in product development
- Strong knowledge of human capabilities and limitations (cognitive, perceptual, motor, biomechanical)
Nice to Have
- Experience with Class II or III medical devices
- Proficiency in planning and executing formative evaluations and human factors validations
- Familiarity with FDA Human Factors Guidance and IEC 62366-1 / IEC 60601-1-6 standards
- Experience leading human factors efforts in a regulated environment
- Background in robotic or software-based medical technologies
Additional Information
- Travel Percentage: 30%
- Individual pay is based on skills, experience, and other relevant factors
- Actual minimum and maximum may vary based on location
