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Job Description

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as a Use-safety Engineering Lead, Human Factors and User Research where you will manage Human Centered Design of Medical Devices and Combination Products. You will also manage usability technology landscaping , usability safety requirements, task analysis and use risk analysis, contributing to the design and development of the product user interface to support safe and effective use of the product for the intended use by the intended users in the anticipated use environment. As part of the Human Factors and User Research, you will report to Lead, Human Factors and User Research and work with mechanical, software, clinical, regulatory, packaging, labeling, and quality engineering disciplines.

How you will contribute:

• Apply human performance and behavior principles, methodologies, and technologies to design user-centered Medical Devices and Combination Products

• Provide use-safety engineering and usability risk management expertise and leadership throughout product development in accordance with internal processes and external standards

• Conduct the known use problems analysis and use related risk analysis for products, updating analyses throughout the design and development of the product user interface.

• Work with HF leads on establishing the use safety product and system-level requirements and specifications, and support in designing Human Factors studies to iteratively evaluate product user interface – including hardware, software, packaging, instructional material, and training.

• Apply knowledge of applicable guidance, regulations, standards, and industry best practices to medical device and combination product design and development process.

• Prepare documentation to support medical device and combination product development activities including design controls.

• Work with regional regulatory bodies in product approval discussions, providing expertise on the use-related risk analysis.

• Draft responses to regulatory Human Factors Information Requests.

• Participate in internal and external quality audits.

• Mentor Human Factors and User Research Leads.

• Contribute to Human Factors standard operating procedures and templates development.

• Collaborate with cross functional team members from mechanical, software, clinical, regulatory, packaging, labeling, and quality engineering disciplines.

• Communicate with internal and external stakeholders.

Minimum Requirements/Qualifications:

• Doctorate degree and 6 years / Master’s degree and 8 years / Bachelor’s degree and 10 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, other relevant degrees in device design or biotech industry.

• A understanding of medical device and combination product usability risk management.

• Understanding and background in implementing Human Factors Engineering and Risk Management regulations and standards, including IEC 62366, HE75, ISO 14971, ISO 13485, 21CFR, and EU MDR.

• Be collaborative and flexible in approach to solving human factors challenges.

• We may ask you for up to 5-10% yearly travel, including domestic and international.

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• Health & Wellness programs including onsite flu shots and health screenings

• Generous time off for vacation and the option to purchase additional vacation days

• Community Outreach Programs and company match of charitable contributions

• Family Planning Support

• Flexible Work Paths

• Tuition reimbursement

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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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