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.