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Lead the Human Centered Design of medical devices and combination products, focusing on user interfaces, packaging, and labeling. Drive the advancement of AI-enabled Human Factors Engineering capabilities and ensure compliance with regional regulatory guidance and quality systems.
Requires a Doctorate with 7+ years, a Master's with 13+ years, or a Bachelor's with 15+ years of experience in Human Factors or related engineering fields. Must have expertise in device design within the biotech or medical device industry.
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
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.
The HFE Lead responsibilities include but are not limited to:
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 evaluating 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 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.
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.
Education & 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.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
U.S. Base Salary Range:
$154,400.00 - $242,550.00
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 unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
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.
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.
Better Health, Brighter Future
We strive to transform lives. While the science we advance is constantly evolving, our core purpose is enduring. For more than two centuries, our values have guided us to do what’s right for patients and for society. We know that changing lives requires us to do things differently. We start by listening to and addressing what really matters to patients, the people who love them, and those in the healthcare system who provide care. And that’s what inspires us all to be bold, push boundaries and set new standards that open up greater opportunities. Read our community guidelines: https://takeda.info/communityguidelines
Offices: Tokyo, JP · 1 Takeda Parkway, Deerfield, Illinois 60015, US · 40 Landsdowne St, Cambridge, Massachusetts 02139, US · Avenida das Nações Unidas, 14.401, Torre Jequitibá - 10°, 11° e 12° andares, São Paulo, 04794-000, BR · 43 Old Oak Rd, Bellville, Western Cape 7550, ZA
