About the role
AI summarisedSenior Human Factors & Usability Engineer responsible for leading human factors activities for medical device development, ensuring usability and safety compliance with regulatory standards. The role involves planning and conducting user research, usability testing, and integrating human factors into the design process.
Consumer ElectronicsFull-timeDesign Engineering
Key Responsibilities
- Lead human factors engineering activities for medical device product development, including user research, task analysis, and usability testing.
- Develop and execute human factors validation plans in compliance with IEC 62366 and FDA guidance.
- Collaborate with cross-functional teams to integrate human factors into the design process.
- Conduct formative and summative usability studies to identify use-related risks and design improvements.
- Analyze user data and provide actionable recommendations to enhance product usability and safety.
- Prepare human factors documentation for regulatory submissions and design history files.
- Support risk management activities by identifying use-related hazards and mitigations.
- Mentor junior engineers and contribute to the development of human factors best practices.
Requirements
- Bachelor's degree in Human Factors Engineering, Industrial Engineering, Mechanical Engineering, Biomedical Engineering, Psychology, or related field.
- Minimum 5 years of experience in human factors/usability engineering within the medical device industry.
- Strong knowledge of human factors standards and regulations, including IEC 62366, ISO 14971, and FDA guidance.
- Experience planning and conducting formative and summative usability studies.
- Proficiency in usability testing methods, task analysis, and heuristic evaluation.
- Excellent analytical and problem-solving skills with attention to detail.
- Strong written and verbal communication skills for technical documentation and cross-functional collaboration.
- Ability to manage multiple projects and priorities in a fast-paced environment.
- Experience with risk management and use-related risk analysis.
- Master's degree preferred.
- Certification in Human Factors (e.g., CPE) is a plus.