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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 Human Factors and User Research Lead - Sr Manager/Associate Director where you will be responsible for Human Centered Design of Medical Devices and Combination Products. You will also be responsible for the usability technology landscaping, usability safety requirements, task analysis and use risk analysis, as well as harness user needs, product requirements, and usability evaluation as inputs into 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 Head, 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. Develop and implement Human Factors and User Research strategy in compliance with regional regulatory guidance and Quality Management System.

• Apply functional 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.

• Conduct exploratory research to gather user insights and design trends.

• Translate user needs into product and system-level requirements and specifications.

• Design and execute Human Factors studies to evaluate product user interface – including hardware, software, packaging, instructional material, and training.

• Create annual budget by product for Human Factors and User Research activities.

• Perform use-safety engineering through Use-Related Risk Analysis.

• Conduct Task and Known Use Problem Analyses.

• Onboard and manage Human Factors, User Research, and Visual Design vendors.

• Interact with regional regulatory bodies for product approval discussions.

• Draft responses to regulatory Human Factors Information Requests.

• Develop Human Factors Summary Reports in compliance with FDA guidance.

• Develop Usability Engineering files in compliance with IEC and ISO standards.

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

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

• Participate in internal and external quality audits.

• Mentor Human Factors and User Research Leads.

• Communicate with internal and external stakeholders.

• Up to 10% yearly travel, including domestic and international.

Minimum Requirements/Qualifications:

• Doctorate degree and 7 years / Master's degree and 13 years / Bachelor's degree and 15 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, other relevant degrees in device design or biotech industry.

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

• Strong understanding and background in implementing Human Factors Engineering and Risk Management regulations and standards, including but not limited to IEC 62366, HE75, ISO 14971, ISO 13485, 21CFR, and EU MDR.

• Ability to be collaborative and resilient in approach to solving human factors challenges.

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.

Base Salary Range: $143,500 to $205,000. Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

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.

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