Human Factors Engineering; HFE Lead - Associate Engineering Fellow; AEF

Job Description Objective

Human Factors Engineering (HFE) Lead - Associate Engineering Fellow (AEF) is responsible for Human Centered Design of Medical Devices and Combination Products. The HFE Lead - AEF will be integral to design and development of product user interface including hardware, software, packaging, labeling, and instruction material to support safe and effective use of the product for the intended use by the intended users in the anticipated use environment.

The HFE AEF will lead the advancement of AI-enabled Human Factors Engineering capabilities across the organization by identifying and prioritizing high‑impact digital transformation initiatives aligned with pipeline and platform device strategies.

• 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, apply 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 of Human Factors standard operating procedures and templates.
• 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.
• Partnering with cross‑functional colleagues across mechanical engineering, software, clinical, regulatory, commercial, data science, digital, and quality disciplines.
• Qualifying and managing Human Factors vendors.
• Supporting internal and external quality audits.
• Communicating with internal and external key stakeholders.
• Mentoring Human Factors Engineering Leads.

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

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.

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

Lexington, MA, U.S.

U.S. Base Salary Range: $ - $. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and…