Human Factors Engineering - Associate Engineering Fellow

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Human Factors Engineering (HFE) Lead – Associate Engineering Fellow (AEF) is responsible for Human Centered Design of Medical Devices and Combination Products.

Lead the design and develop of product user interface—including hardware, software, packaging, labeling, and instruction materials—to support safe and effective product use.

• Lead and execute Human Factors strategy in compliance with regional regulatory guidance.
• Drive and oversee User Research strategy in compliance with Quality Management System.
• Develop Human Factors Product and System level requirements in alignment with Target Product Profile.
• Conduct exploratory research to gather user insights, design trends and evaluate user interface concepts.
• Translate user needs into user experience and interface requirements and specifications.
• Design and execute Human Factors studies to iteratively evaluate product user interface—including hardware, software, packaging, instructional material, and training.
• Conduct Task and Known Use Problem Analyses.
• Perform use‑safety engineering through Use‑related Risk Analysis.
• Develop Human Factors Validation Protocols and Reports.
• Manage Human Factors, Industrial Design, and User Research vendors.
• Support regulatory Human Factors Information Requests.
• Develop Human Factors Summary Reports in compliance with FDA guidance.
• Develop Usability Engineering Files in compliance with IEC and ISO standards.
• Lead development of Human Factors standard operating procedures and templates.
• Apply functional knowledge of applicable guidance, regulations, standards, and industry best practices to medical device and combination product design and development process.
• Prepare documentation to support medical device and combination product development activities including design controls.
• Collaborate with cross‑functional team members from mechanical, software, clinical, regulatory, and quality engineering disciplines.
• Qualify and manage Human Factors vendors.
• Support internal and external quality audits.
• Communicate with internal and external key stakeholders.
• Mentor Human Factors Engineering Leads.

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

• Role primarily involves cognitive and analytical tasks; good physical health is essential to visit manufacturing sites or conduct user testing in clinical environments, which may involve walking, standing or other physical activities.
• Depending on specific responsibilities, may need to travel to clinical sites, supplier facilities or other locations for research and testing purposes.

Up to 20% yearly travel, including domestic and international.

U.S. base salary range: $154,400 – $242,550. Actual salary may depend on qualifications, experience, skills, education, licenses and location. U.S. employees may be eligible for short‑term and/or long‑term incentives, medical, dental, vision insurance, a 401(k) plan and company match, short‑term and long‑term disability coverage, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, well‑being benefits, up to 80 hours of sick time and new hires accrue up to 120 hours of paid vacation.

Location:

Lexington, MA.

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