Human Factors Engineering Lead Position Available In Middlesex, Massachusetts

You will need to login before you can apply for a job. Human Factors Engineering Lead
Employer
Takeda
Location
Lexington, Massachusetts
Start date
Jun 1, 2025
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Job Details 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’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Human Factors Engineering (HFE) Lead is responsible for Human Centered Design of Medical Devices and Combination Products. The HFE Lead 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.

Responsibilities:

The HFE Lead responsibilities include but are not limited to: Implementing Human Factors strategy in compliance with regional regulatory guidance. Implementing 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. Contributing 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.

Qualifications:

PhD and 3+ years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, other relevant degrees in device design or biotech industry. Master’s degree and 9+ years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, other relevant degrees in device design or biotech industry. Bachelor’s degree and 11+ 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. 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.

For Location:

Lexington, MA U.S.

Base Salary Range:

$137,000.00 – $215,270.00 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-termincentives. 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. 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. LocationsLexington, MA Worker TypeEmployee Worker Sub-TypeRegular Time TypeFull time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Company For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation. Today, our organization spans the globe—colleagues across business units and functions face challenges head-on to deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. As a values-based, R D-driven biopharmaceutical leader headquartered in Japan, we focus our R D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R D investments in Plasma-Derived Therapies and Vaccines. In addition to our R D efforts, we’re laser-focused on harnessing the power of data, digital, and technology to improve health outcomes for patients across the globe. Since our founding in Japan, integrity and putting patients first have been at the heart of our identity. We’re proud of our employees and their commitment to improving the quality of life for patients, and to working with our partners in health care in approximately 80 countries and regions. With each new breakthrough comes opportunities to develop your career, hone new skills, and create a brighter future For more information, visit jobs.takeda/ Company info