Sr. Manager, Human Factors and User Experience

Role Summary

Senior Manager, Human Factors and User Experience. Develop HF strategies and lead/coordinate Human Factors activities to deliver best-in-class Usability and enhanced user experience for Takeda Plasma Derived Therapy users. Ensure regulatory success by ensuring HFE work complies with IEC 62366 and regulatory expectations (e.g., FDA). Drive HF/UX initiatives in early-stage, development, and lifecycle management projects, ensuring strategic execution and timely delivery. Location: Lexington, MA.

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 and drive HFE & UX input for UI 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 report) in compliance with IEC 62366 & regulatory expectations.
• Provide input to Use-Related Risk Analysis.
• Identify and oversee opportunities to enhance and harmonize user experience.
• Work 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 instruction material to support safe and effective use of the product.
• Apply functional knowledge of guidance, regulations, standards, and industry best practices to the product development process.
• Support or coordinate other internal or external HFE/UX team members as needed.

Qualifications

• 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 ISO 14971, IEC 60601-1-8, HE75
• Education, Behavioral Competencies and Skills:
  • Doctorate degree and 4 years of HF Engineering, Usability Engineering, User Experience or related field in medical device/biotech or consumer technology
  • OR Master’s degree and 8 years of HF Engineering, Usability Engineering, User Experience or related field in medical device/biotech or consumer technology
  • OR Bachelor’s degree and 12 years of HF Engineering, Usability Engineering, User Experience or related field in medical device/biotech or consumer technology