Takeda · 1 day ago
Human Factors Engineering - Associate Engineering Fellow
Lexington, MA
Full-time
Onsite
Senior Level, Lead/Staff
$154K/yr - $241K/yr
10+ years expTakeda is a biopharmaceutical company focused on bringing better health to patients through science. The Human Factors Engineering Lead - Associate Engineering Fellow is responsible for the Human Centered Design of Medical Devices and Combination Products, leading the execution of Human Factors strategy and overseeing User Research strategy to ensure safe and effective use of products.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
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 to gather user insights and design trends and evaluate user interface concepts
Translating user needs into user experience and interface requirements and specifications
Designing and executing Human Factors studies to iteratively evaluating product user interface – including hardware, software, packaging, instructional material, and training
Conducting Task and Known Use Problem Analyses
Performing use-safety engineering through Use-related Risk Analysis
Developing Human Factors Validation Protocols and Reports
Managing Human Factors, Industrial Design, and User Research vendors
Supporting regulatory Human Factors Information Requests
Developing Human Factors Summary Reports in compliance with FDA guidance
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
Collaborating with cross functional team members from mechanical, software, clinical, regulatory, and quality engineering 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
Qualification
Required
Doctorate degree and 10+ 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
Good physical health is essential
Ability to visit manufacturing sites or conduct user testing in clinical environments, which might involve walking, standing, or other physical activities
Ability to travel to clinical sites, supplier facilities, or other locations for research and testing purposes
Benefits
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
A tuition reimbursement program
Paid volunteer time off
Company holidays
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
Pharmaceutical Technology
2026-01-11
2026-01-09
Company data provided by crunchbase