JOB SUMMARY

Work requires independent human factors research, analysis, and evaluation using standard human factors engineering theories, principles, and data to facilitate user-centered product design and development.  Assignments include applying HFE to system user interface definition, design, and evaluation over the product life cycle, including support for sustaining and ideation projects.  Duties are assigned to provide experience and familiarization with engineering methods, independent thinking, leadership opportunities, and company practices and policies.

ESSENTIAL DUTIES

• With guidance, leads the strategy, planning, and execution of human factors engineering activities and validation for small to medium sized product development projects.
• Advises, reviews, and approves HFE work for projects with limited scope or lower business priority.
• Contributes to the HFE work for larger projects with the direction from senior engineers.
• 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 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.
• Builds prototypes of user interfaces needed for usability testing, including graphical user-interface, hardware, or disposable components, at the direction of the designers. 
• Supports the development of internal tools for human factors 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).

OTHER DUTIES AND RESPONSIBILITIES

• Work assignments may require additional development and a maturing or broadening of in-depth engineering skill(s).
• Collaborate with other functional groups, technical disciplines, and levels of management including other engineering disciplines, Product Owners, UX Designers, Technical Product Leads, Marketing, Regulatory, Project Managers, and Global Product Support and Training.

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 for medical devices, specifically those applied by Human Factors (i.e. URA, UFMEA, AFMEA, UEA techniques), preferred.

Skills

• Requires working 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 interactive skills in cross-functional participation and influence, acceptance of guidance, technical leadership, project management, coordination with cross-functional team members, and strong team-player mentaliy.
• Ability to influence without authority and demonstrate to internal colleagues the benefits of HFE and user-centered design.
• Ability to learn and use prototyping tools, such as GUI-design software and 3D-printing (i.e. Additive manufacturing, Adobe Photoshop, Solidworks, Invision, JustInMind).
• Ability to write human factors protocols and reports for regulatory requirements and submissions.
• Problem solving skills to diagnose root causes of human factors issues and recommend user-centered design solutions.
• Highly organized and able to work efficiently across multiple projects in parallel.
• Demonstrated ability to communicate and present data and results effectively verbally, in writing, and through presentations.
• Knowledge and use of relevant PC software applications and skills to use them effectively. 

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

PHYSICAL REQUIREMENTS

General Labor Environment requirements include: use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment.

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Additional Physical Requirements

Requires travel based on business needs.

At Terumo Blood and Cell Technologies, 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. For us, it’s about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.