Sr. Manager, Human Factors and User Experience Job at BioSpace in Lexington

Sr. Manager, Human Factors and User Experience

BioSpace is seeking a Sr. Manager to develop human factors (HF) strategies and lead HF activities to deliver best‑in‑class usability and enhanced user experience for Takeda Plasma Derived Therapy users.

Objectives / Purpose

Develop HF strategies and lead/coordinate Human Factors activities 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 complies with IEC 62366 & regulatory body expectations.
Drive HF/UX initiatives in early stage, development, and LCM projects, ensuring strategic and rigorous execution and timely delivery.

Accountabilities

• Lead/coordinate HFE & User Experience strategy for 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 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 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.
• Apply 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 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, Behavioral Competencies and Skills

• Doctorate degree and 4 years of Human Factors Engineering, Usability Engineering, User Experience, and other relevant degrees in a medical device or biotech industry or consumer technology.
• Master’s degree and 8 years of Human Factors Engineering, Usability Engineering, User Experience, and other relevant degrees in a medical device or biotech industry or consumer technology.
• Bachelor’s degree and 12 years of Human Factors Engineering, Usability Engineering, User Experience, and other relevant degrees in a medical device or biotech industry or consumer technology.

Compensation & Benefits Summary

U.S. Base Salary Range: $137,000.00 – $215,270.00.
U.S. based employees may be eligible for short‑term and/or long‑term incentives, 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.

Location

Lexington, MA

Worker Type

Employee

Time Type

Full time

Job Exempt

Yes