Engineer 3 - Human Factors

As a Human Factors Engineer 3 at Terumo Blood and Cell Technologies, you will be involved in designing life-changing medical devices that support blood and cell therapies. Your role will include leading human-centered design initiatives to ensure that the products are safe, intuitive, and effective for both clinicians and patients. By collaborating closely with cross-functional teams such as R&D, Quality, Regulatory, and Clinical, you will conduct user research, usability testing, and risk assessments to optimize device interfaces and workflows. This is a great opportunity for you to contribute to the future of healthcare by driving innovation and improving patient outcomes in a fast-paced, mission-driven environment. **Key Responsibilities:** - Lead the strategy, planning, and execution of human factors engineering activities and validation for product development projects of all sizes. - Conduct user-centered research including interviews, contextual inquiries, task analyses, and anthropomorphic evaluations for the development of user and environment profiles, use specification, use cases, and usability/user interface requirements. - Ensure that product development projects are following HFE process compliant with all Company policies and procedures as well as existing IEC Usability standards, AAMI Human Factors standards, and/or FDA Human Factors Guidances. - Analyze field data and review literature and publications to identify existing usability issues with on-market products. - Collaborate with cross-functional teams to create and maintain use-related risk analyses and user interface requirements. - Support the development of internal tools for human factors data capture, analysis, and testing. - Contribute to identifying and developing design and development process improvements. - Keep abreast of regulations and best practices for medical device human factors engineering. **Qualification Required:** - Bachelor of Science Degree in Usability/Human Factors Engineering, Biomedical Engineering, Systems Engineering, or related research-based degree, preferred. - Minimum 4 years of experience in Human Factors/Usability in medical devices and familiarity with existing IEC Usability standards, AAMI Human Factors standards, and/or FDA Human Factors Guidance, preferred. - Strong technical writing skills to produce human factors protocols and reports for regulatory requirements and submissions. - Demonstrated ability to communicate and present data and results effectively verbally, in writing, and through presentations at major project milestones. In addition to the above, Terumo Blood and Cell Technologies is a part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan. In 2019, the company reached $1 billion in revenue and employs nearly 7,000 associates globally. The core values of the company include Respect, Integrity, Care, Quality, and Creativity, which guide their actions and mission of contributing to society through healthcare.,