Engineer III, Human Factors Engineering

Job Description

The Engineer III, Human Factors Engineering (HFE) supports the Human-Centered research, design, and development of Medical Devices and Combination Products. Key responsibilities include:

• 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 evaluate 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.
• Serving as a liaison between 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

Requirements include:

• A Master's degree of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, other relevant degrees in device design or biotech industry.
• Or, a 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.
• Or, an 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 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.

Compensation and Benefits

Takeda offers a competitive compensation package with a base salary range of $89,900.00 - $141,240.00 for the position in Lexington, MA. Benefits include:

• Equitable pay for all employees.
• Transparency in pay practices.
• Compliance with state and local minimum wage requirements.
• Information about benefits available upon request.

EEO Statement

Takeda is committed 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.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Exempt

Yes