Takeda logo

Sr. Manager, Human Factors and User Experience

Takeda
Full-time
Remote friendly (Lexington, MA)
United States
$137,000 - $215,270 USD yearly
Clinical Research and Development

Want to see how your resume matches up to this job? A free trial of our JobsAI will help! With over 2,000 biopharma executives loving it, we think you will too! Try it now — JobsAI.

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

Apply now
Share this job