Human Factors Engineering (HFE) Lead - Associate Engineering Fellow (AEF)

USA - 3316 Takeda Development Center Americas, Inc.; Lexington (MA); On-site; USD 154,000 - 243,000; Full time

Job summary

Takeda in Lexington, MA is seeking an HFE Lead - Associate Engineering Fellow to drive human-centered design of medical devices and combination products, shaping product UI across hardware, software, packaging and labeling to ensure safe use.

The role leads AI-augmented human factors initiatives, develops user research, creates usability files, manages vendors, and partners with cross-functional teams, with up to 20% travel; advanced degrees and many years experience required.

Qualifications

• Doctorate or master's or bachelor's degree with extensive Human Factors/biomedical/industrial engineering experience in device design or biotech industry.
• Experience leading Human Factors strategy and user research within regulated medical device environments.
• Strong understanding of IEC/ISO usability engineering standards and design controls.

Responsibilities

• Lead and execute Human Factors strategy in compliance with regulatory guidance.
• Develop and manage Human Factors Requirements and Usability Engineering Files.
• Oversee User Research and data collection, including AI-augmented methods.
• Manage Human Factors vendors and contracts, and mentor HF leads.
• Prepare regulatory documentation and support audits.

Skills

Human Factors Engineering

Biomedical Engineering

Industrial Engineering

AI-enabled design

Regulatory compliance

Vendor management

Education

Doctorate degree

Master's degree

Bachelor's degree

Job description

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 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. 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.

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: Learn about our commitment to Equal Employment Opportunity (EEO).

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