Human Factors Engineering - Associate Engineering Fellow at Takeda Pharmaceuticals

Lexington, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

04 Jul, 26

Salary

242550.0

Posted On

05 Apr, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Human Factors Engineering, Medical Device Design, Combination Products, User Research, Usability Engineering, Risk Analysis, Regulatory Compliance, FDA Guidance, IEC Standards, ISO Standards, Design Controls, Task Analysis, User Interface Design, Cross-functional Collaboration, Vendor Management, Mentoring

Industry

Pharmaceutical Manufacturing

Description

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. Job Description 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 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 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. Education & Qualifications 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 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. For Location: Lexington, MA 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. 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. Locations Lexington, MA Worker Type Employee Worker Sub-Type Regular Time Type Full 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. Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer. For applicants of U.S and Puerto Rico positions: Click here to learn about our commitment to Equal Employment Opportunity (EEO). If you are limited in the ability to use our job application tool, or otherwise require a reasonable accommodation for a disability please click here.

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Responsibilities

The Human Factors Engineering Lead is responsible for the human-centered design of medical devices and combination products, ensuring safe and effective user interaction. This includes leading user research, conducting usability studies, and managing regulatory documentation in compliance with industry standards.