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Takeda · 1 day ago

Sr. Manager, Human Factors and User Experience

Lexington, MA

Full-time

Hybrid

Mid, Senior Level

$137K/yr - $215K/yr

4+ years exp

Takeda is a leading company in the healthcare sector, focusing on providing innovative therapies. The Sr. Manager of Human Factors and User Experience will develop strategies and lead activities to enhance usability and user experience for Plasma Derived Therapy users, ensuring compliance with regulatory standards.

BiotechnologyHealth CareManufacturingMedicalPharmaceutical

Responsibilities

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

Qualification

Human Factors EngineeringUsability EngineeringUser ExperienceIEC 62366 complianceMedical device standardsHuman Factors research methodsFormativeSummative studiesTeam coordinationRegulatory submissionsUser interface design

Required

Doctorate degree and 4 years of Human Factors Engineering, Usability Engineering, User Experience and other relevant degrees in 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 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 medical device or biotech industry or consumer technology

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