Engineer III, Human Factors Engineering

USA - 3316 Takeda Development Center Americas, Inc.; Lexington (MA); On-site; USD 90,000 - 141,000; Full time

Job summary

Takeda in Lexington, MA, is seeking an Engineer III, Human Factors Engineering to drive human-centered research and development for medical devices and combination products. The role emphasizes UI/UX across hardware, software, packaging, labeling, and training, with a push toward AI-enabled HF tools and methodologies.

Responsibilities include planning user studies, supporting risk management, and coordinating HF/vendor activities within QMS-regulated environments.

Qualifications

• Master's degree in Human Factors Engineering, Biomedical Engineering, Industrial Engineering or related device/biotech field.
• Bachelor's degree plus 2+ years of relevant Human Factors or Biomedical/Industrial Engineering experience.
• Associate’s degree plus 4+ years of relevant experience in HF engineering or related fields.

Responsibilities

• Support the development and execution of Human Factors activities in compliance with regulatory guidance.
• Contribute to User Research planning and execution per QMS requirements.
• Support HF product and system level requirements aligned with Target Product Profile.
• Conduct exploratory and AI-augmented research to generate high-quality user data.
• Execute HF studies to iteratively evaluate product UI across hardware, software, packaging, and instructions.
• Assist data-driven risk management including predictive modeling.
• Contribute to HF Validation Protocols and Reports.
• Coordinate and manage HF and User Research vendors.

Skills

Human Factors Engineering

User Research

Regulatory Compliance

AI-augmented Research

Cross-functional Collaboration

Education

Master's degree in Human Factors Engineering/Biomedical/Industrial Engineering

Bachelor's degree with 2+ years' relevant experience

Associate’s degree with 4+ years' relevant experience

Job description

Job Description Objective

The Engineer III, Human Factors Engineering (HFE) is responsible for supporting the Human-Centered research, design, and development of Medical Devices and Combination Products. This role contributes to the design and evaluation of product user interface, including hardware, software, packaging, labeling, and instructional materials, to help ensure safe and effective use of the product by the intended users in the anticipated use environment. The Engineer III, HFE also contributes to the adoption of digital and AI-enabled Human Factors Engineering tools and methodologies.

Responsibilities

• Supporting the development and execution of Human Factors Engineering activities in compliance with regional regulatory guidance.
• Contributing to User Research planning and execution in accordance with Quality Management System requirements.
• Supporting Human Factors product and system level requirements aligned 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.
• Executing Human Factors studies to iteratively evaluating product user interface – including hardware, software, packaging, instructional material, and training.
• Supporting data driven risk management approaches, including predictive modeling.
• Contributing to Human Factors Validation Protocols and Reports.
• Supporting the selection, coordination, and management of Human Factors and User Research vendors.
• 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.
• Partnering with cross-functional colleagues across mechanical engineering, software, clinical, regulatory, commercial, data science, digital, and quality disciplines.
• Supporting internal and external quality audits.
• Communicating with internal and external key stakeholders.

Education & Qualifications

• Master's degree of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, other relevant degrees in device design or biotech industry.
• Bachelor's degree and 2+ years of relevant industry experience in Human Factors Engineering, Biomedical Engineering, Industrial Engineering, other relevant degrees in device design or biotech industry.
• Associate’s degree and 4+ years of relevant industry experience in Human Factors Engineering, Biomedical Engineering, Industrial Engineering, other relevant degrees in device design or biotech industry.

Physical Health Requirements

While the role of an Engineer III, HFE 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 and research facilities, which might involve walking, standing, or other physical activities.

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: $89,900.00 - $141,240.00. 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. For information about our benefits.

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 and Job Details

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.

Company Culture

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.