Sr. Manager, Human Factors and User Experience

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Job Description

OBJECTIVES/PURPOSE:

Develop HF strategies and Lead/coordinate Human Factors activities in order to provide best-in-class usability and enhanced user experience for Takeda Plasma Derived Therapy users.

Ensure regulatory success by making sure that the HFE work is done in compliance with IEC 62366 & regulatory body (example, FDA) expectations.

Drive HF/UX initiatives in early stage, development, and LCM projects, ensuring strategic and rigorous execution and timely delivery.

ACCOUNTABILITIES:

Senior Manager is responsible for Human Centered Design of Medical Devices and Combination Products

• Lead/coordinate HFE & User Experience strategy for the assigned medical devices, combination products and digital solutions forming part of the Takeda therapy ecosystem.
• 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 packaging, labeling, and instruction material to support safe and effective use of the product.
• Applying functional knowledge of applicable guidance, regulations, standards, and industry best practices to medical device and combination product design and development process.
• Support or coordinate other internal or external HFE/UX team members on any of the above tasks as needed. 

Technical/Functional (Line) Expertise

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

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Doctorate 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
• Master's degree and 8 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 12 years of Human Factors Engineering, Usability Engineering, User Experience and other relevant degrees in medical device or biotech industry or consumer technology

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Lexington, MA

U.S. Base Salary Range:

$137,000.00 - $215,270.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. 

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. 

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

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.