Human Factors Engineering (HFE) Lead - Associate Engineering Fellow (AEF)

Responsibilities

• Leading and executing Human Factors strategy in compliance with regional regulatory guidance.
• Driving and overseeing User Research strategy in compliance with Quality Management System.
• Developing Human Factors Product and System level requirements in alignment with Target Product Profile.
• Conducting exploratory research and AI-augmented research to generate high-quality user data, including digital ethnography, remote usability platforms, and synthetic user simulations.
• Translating user needs into user experience and interface requirements and specifications.
• Designing and executing Human Factors studies to iteratively evaluate product user interface – including hardware, software, packaging, instructional material, and training.
• Performing use-safety engineering, applying advanced, data-driven risk management approaches, including predictive modeling and AI-assisted signal detection.
• Developing and managing Human Factors Validation Protocols and Reports.
• Managing Human Factors, Design, and User Research vendors.
• Creating and implementing Human Factors regulatory strategies.
• Developing Usability Engineering Files in compliance with IEC and ISO standards.
• Leading development to Human Factors standard operating procedures and templates development.
• Applying functional knowledge of applicable guidance, regulations, standards, and industry best practices to medical device and combination product design and development process.
• Preparing documentation to support medical device and combination product development activities including design controls.
• P业内跨职能团队合作，包括机械工程、软件、临床、监管、商业、数据科学、数字和质量领域。
• Qualifying and managing Human Factors vendors.
• 支持内部和外部质量审计。
• 与内部和外部关键利益相关者沟通。
• 指导人类因素工程主管。

Requirements

• Doctorate degree and 7+ years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, other relevant degrees in device design or biotech industry.
• OR, Master's degree and 13+ years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, other relevant degrees in device design or biotech industry.
• OR, Bachelor's degree and 15+ years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, other relevant degrees in device design or biotech industry.

Physical Health Requirements

• While the role of a Human Factors Engineering Lead primarily involves cognitive and analytical tasks, good physical health is essential. Engineers may need to visit manufacturing sites or conduct user testing in clinical environments, which might involve walking, standing, or other physical activities.
• Depending on the role and specific responsibilities, a Human Factors Engineering Lead may need to travel to clinical sites, supplier facilities, or other locations for research and testing purposes.

Travel Requirements

This position may require up to 20% yearly travel, including domestic and international.