Takeda · 2 months ago
Sr. Manager, Human Factors and User Experience
Lexington, MA
Full-time
Hybrid
Mid, Senior Level
4+ years expTakeda is a leading global biopharmaceutical company, and they are seeking a Sr. Manager for Human Factors and User Experience. This role involves developing HF strategies and leading Human Factors activities to ensure best-in-class usability and compliance with regulatory standards for Takeda's Plasma Derived Therapy users.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
Lead/coordinate HFE & User Experience strategy for the assigned medical devices, combination products and digital solutions forming part of the Takeda therapy ecosystem
Gain a deep understanding around the needs of the users of PDT therapies, devices and technologies and drive HFE & UX input for user interface design and development (hardware, GUI, labeling etc.)
Oversee or generate the HFE deliverables throughout medical device development (Examples: HFE Plan, Task Analysis, Use Specification, User-interface requirements, HFE/UE Summary report etc.) in compliance with IEC 62366 & regulatory agency expectations
Provide input to Use-Related Risk Analysis
Identify & oversee/execute on opportunities for enhancing and harmonizing user experience
Work with external partners to conduct formative and summative studies
Author or coordinate authoring of HFE sections of the regulatory submissions (example, 510K)
Coordinate or lead the execution of the design and development of packaging, labeling, and instruction material to support safe and effective use of the product
Applying functional knowledge of applicable guidance, regulations, standards, and industry best practices to medical device and combination product design and development process
Support or coordinate other internal or external HFE/UX team members on any of the above tasks as needed
Qualification
Required
Doctorate degree and 4 years of Human Factors Engineering, Usability Engineering, User Experience and other relevant degrees in medical device or biotech industry or consumer technology
Master's degree and 8 years of Human Factors Engineering, Usability Engineering, User Experience and other relevant degrees in medical device or biotech industry or consumer technology
Bachelor's degree and 12 years of Human Factors Engineering, Usability Engineering, User Experience and other relevant degrees in medical device or biotech industry or consumer technology
In-depth understanding of Human Factors research methods
Experience with medical device and combination products
Experience conducting Human Factors formative and summative studies
Familiarity with IEC 62366-1/2, FDA HF Guidance, EU MDR usability expectations
Working knowledge of relevant medical device standards ISO 14971, IEC 60601-1-8, HE75
Benefits
U.S. based employees may be eligible for short-term and/ or long-term incentives.
U.S. based employees may be eligible to participate in 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, and well-being benefits, among others.
U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue 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
2026-01-14
Pharmaceutical Technology
2026-01-11
Company data provided by crunchbase