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Lead Of Human Factors and User Research

Lexington, Massachusetts


Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

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  • Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.

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Lead Of Human Factors and User Research

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Job ID R0036497 Date posted 05/10/2021 Location Lexington, Massachusetts

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as Human Factors and User Research Lead in our Lexington, MA office. 

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. 

At Medical Devices Center of Excellence, our job is turning concepts into reality. We begin with a concept and then we build a framework to realize it. The goal is to find creative ways to improve our products and processes and turn possibilities into real benefits for our patients. We are responsible for medical devices & combination products that covers advanced drug delivery (including device-drug product qualification testing), diagnostics and eHealth (software and connected devices). 


 Human Factors and User Research Lead is responsible for Human Centered Design of Medical Devices and Combination Products. The HFUR Lead will harness user needs, product requirements, task analyses, use risk analyses, 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.


The HFUR Lead responsibilities include but are not limited to:

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

  • Develop and implement Human Factors and User Research strategy in compliance with regional regulatory guidance and Quality Management System.

  • 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 iteratively 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 regular 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.

  • 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.

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

  • Participate in internal and external quality audits.

  • Hire, mentor, and manage Human Factors and User Research Leads.

  • Communicate with internal and external stakeholders.


Education Requirements: 

  • Doctorate degree and 8 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, other relevant degrees in device design or biotech industry.

  • Master's degree and 10 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, other relevant degrees in device design or biotech industry.

  • Bachelor's degree and 12 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, other relevant degrees in device design or biotech industry.


  • May require approximately up to 20% travel, domestic and international


  • 401(k) with company match and Annual Retirement Contribution Plan

  • Tuition reimbursement

  • Company match of charitable contributions

  • 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

Empowering Our People to Shine

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*This job posting excludes CO applicants*


Lexington, MA

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Full time

Job ID R0036497
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