Sr. Manager, Human Factors and User Experience

Role Summary

Sr. Manager, Human Factors and User Experience overseeing HF strategies and activities to deliver best-in-class usability and enhanced user experience for Takeda Plasma Derived Therapy users. Ensure regulatory compliance with IEC 62366 and applicable regulatory expectations; drive HF/UX initiatives across development stages.

Responsibilities

• Lead/coordinate HFE & User Experience strategy for assigned medical devices, combination products, and digital solutions within the Takeda therapy ecosystem.
• Understand user needs for PDT therapies, devices, and technologies; drive HFE & UX input for user interface design and development (hardware, GUI, labeling).
• Oversee or generate HFE deliverables throughout medical device development (e.g., HFE Plan, Task Analysis, Use Specification, UI requirements, HFE/UE Summary) in compliance with IEC 62366 and regulatory expectations.
• Provide input to Use-Related Risk Analysis.
• Identify and oversee opportunities to enhance and harmonize user experience.
• Collaborate with external partners to conduct formative and summative studies.
• Author or coordinate HFE sections of regulatory submissions (e.g., 510K).
• Coordinate or lead design and development of packaging, labeling, and instructions to support safe and effective product use.
• Apply knowledge of applicable guidance, regulations, standards, and industry best practices to the design and development process.
• Support or coordinate other internal or external HFE/UX team members as needed.

Qualifications

• In-depth understanding of Human Factors research methods.
• Experience with medical devices 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 ISO 14971, IEC 60601-1-8, HE75.

Education

• Doctorate with 4 years of HF Engineering/Usability/UX or related; OR
• Master's with 8 years of HF Engineering/Usability/UX or related; OR
• Bachelor's with 12 years of HF Engineering/Usability/UX or related

Location

Lexington, MA