Engineer 2 - Human Factors

About the role

At Terumo Blood and Cell Technologies, our 8,000+ global associates come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere. We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient's life every second of every day and are committed to increasing the number of patients we serve.

Responsibilities

• Supports the strategy, planning, and execution of human factors engineering activities for new product development projects and sustaining projects with impacts to the user interface.
• Advises, reviews, and approves HF impact assessments for product design changes.
• Conducts user-centered research including interviews, contextual inquiries, task analyses, and anthropomorphic evaluations for development of user and environment profiles, use specification, use scenarios, and usability/user interface requirements.
• Exercises independent judgment in usability testing methodology, data collection, data analysis, conclusions, and design recommendations at various stages of product development from early prototypes through formal validation testing.
• Ensures 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 and NMPA Human Factors Guidance.
• Analyzes field data and reviews literature and publications to identify existing usability issues with on-market products.
• Works with cross-functional teams to create and maintain use-related risk analyses and user interface requirements.
• Actively collaborates in prototype development of user interfaces, including software, graphical user-interface, hardware or disposable components, and labeling and training.
• Supports and contributes to the development of internal tools and best practices for human factors engineering processes, data capture, analysis, and testing.
• Reinforces customer empathy and human-centered design approach across the organization.
• Keeps abreast of regulations and best practices for medical device human factors engineering (e.g. IEC 62366, AAMI HE75, FDA Applying Human Factors and Usability Engineering to Medical Devices).

Requirements

Minimum Qualification Requirements:

• Education: Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Bachelor of Science Degree in Usability/Human Factors Engineering, Biomedical Engineering, Systems Engineering or related research-based degree, preferred.
• Experience: Minimum 2 years experience. Experience with Human Factors/Usability in medical devices and familiarity with existing IEC Usability standards, AAMI Human Factors standards and/or FDA Human Factors Guidance, preferred.
• Experience with risk management activities applied by Human Factors to medical devices (i.e. URA, UFMEA, AFMEA, UEA techniques), preferred.

Skills

• Requires in depth knowledge of product design and development process specific to medical devices.
• Requires working knowledge of human factors, design controls, and risk management regulations, standards, and guidances for medical devices.
• Requires strong interactive skills in general communication, cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross-functional team members, team behavior.
• Provides support for subordinates, junior engineers, technicians, and management, when needed.
• Demonstrated ability to communicate and present data and results effectively verbally, in writing, and through presentations to both technical and non-technical audiences.
• Ability to influence without authority to drive user-centered design across functional partners.
• Ability to moderate usability studies in a manner that produces reliable data with minimal bias.
• Ability to learn and use prototyping and design tools, such as GUI-design software (e.g. Figma).
• Strong technical writing skills to produce human factors protocols and reports for regulatory requirements and submissions.
• Critical-thinking and problem-solving skills to diagnose root causes of human factors issues and recommend evidence-based, user-centered design solutions.
• Highly organized and able to work efficiently across multiple projects in parallel.
• Knowledge and use of relevant PC software applications and skills to use them effectively.

Benefits

We provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates.

Pay

Target Pay Range: $86,400.00 to $108,000.00 - Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data

Schedule

Target Bonus on Base: 7.0%