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.
• Pricing and communicating with internal and external key stakeholders.
• Mentoring Human Factors Engineering Leads.

Qualifications

• 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.

Compensation and Benefits Summary

• U.S. Base Salary Range: $154,400.00 - $242,550.00
• Short-term and/ or long-term incentives.
• Medical, dental, vision insurance.
• 401(k) plan and company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off.
• Company holidays.
• Well-being benefits.
• Sick time.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.