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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 a Staff Human Factors and User Experience Engineer based 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. Here, you will be a vital contributor to our inspiring, bold mission.

POSTITION OBJECTIVE

Lead/coordinate Human Factors programs in order to provide best in class usability and enhanced user experience for Takeda device users
Ensure regulatory success by making sure that the HFE work is done in compliance with IEC 62366 & regulatory body (example, FDA) expectations.
Partner and influence peers within device, clinical, commercial, regulatory and quality organizations to drive improvement of device development processes.

Leadership/People

No. of direct reports: 0

ACCOUNTABILITIES

Lead/coordinate HFE & User Experience strategy for the assigned medical devices and combination products.
Gain a deep understanding around the needs of the users of PDT therapies, devices and technologies and drive HFE & UX input for user interface design and development (hardware, GUI, labeling etc.)
Oversee or generate the HFE deliverables throughout medical device development (Examples, HFE Plan ,Task Analysis, Use Specification, User-interface requirements, HFE/UE Summary report etc.) in compliance with IEC 62366 & regulatory agency expectations
Provide input to Use-Related Risk Analysis
Identify & oversee/execute on opportunities for enhancing and harmonizing user experience.
Work with external partners to conduct formative and summative studies.
Author or coordinate authoring of HFE sections of the regulatory submissions (example, 510K)
Coordinate or lead the execution of the design and development of Instructions for Use (IFU).
Coordinate or execute on post launch Human Factors activities
Support or coordinate other internal or external HFE/UX team members on any of the above tasks as needed.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

In-depth understanding of Human Factors research methods
Experience with medical device and/or combination product
Experience conducting Human Factors formative and summative studies.
Familiarity with IEC 62366-1/2, FDA HF Guidance's, EU MDR usability expectations
Working knowledge of relevant medical device standards ISO 14971, IEC 60601-1-8, HE75

Leadership

Effective oral and written communication skills
This role is the sole Human Factors Engineer on site and will be trained to enter a management role overtime.

Decision-making and Autonomy

Ability to make decisions on HF strategy, testing execution, and documentation best practices

Interaction

Active collaboration with internal cross-functional teams and external stakeholders

Innovation

Finding innovative solutions for enhancing usability and user experience

Complexity

Ability to work on multiple products with varying degrees of complexity.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS

Doctorate degree and 2 years of Human Factors Engineering, Usability Engineering, User Experience and other relevant degrees in medical device or biotech industry or consumer technology.

OR

Master's degree and 4 years of Human Factors Engineering, Usability Engineering, User Experience and other relevant degrees in medical device or biotech industry or consumer technology

OR

Bachelor's degree and 6 years of Human Factors Engineering, Usability Engineering, User Experience and other relevant degrees in medical device or biotech industry or consumer technology

WHAT TAKEDA CAN OFFER YOU

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

Discover more at takedajobs.com

No Phone Calls or Recruiters Please.

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

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.

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

Staff Engineer, Human Factors and User Experience

Job Type