Engineer 3

Requisition ID:
34211

At Terumo Blood and Cell Technologies, our 7,000+ global associates are proud to come to work each day, knowing that what we do impacts the lives of patients around the world.

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 continuing to increase the number of patients we serve.

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Consider joining our team and unlock your potential.

As a Human Factors Engineer 3, you'll be at the forefront of designing life-changing medical devices that support blood and cell therapies. In this influential role, you'll lead human-centered design initiatives to ensure our products are safe, intuitive, and effective for both clinicians and patients. Collaborating closely with cross-functional teams—including R&D, Quality, Regulatory, and Clinical—you'll conduct user research, usability testing, and risk assessments to optimize device interfaces and workflows. If you're driven by innovation, passionate about improving patient outcomes, and thrive in a fast-paced, mission-driven environment, this is your opportunity to make a lasting impact in the future of healthcare.

Essential Duties

• Leads the strategy, planning, and execution of human factors engineering activities and validation for product development projects of all sizes.
• Advises, reviews, and approves HFE work for projects with limited scope or lower business priority.
• Conducts user-centered research including interviews, contextual inquiries, task analyses, and anthropomorphic evaluations for development of user and environment profiles, use specification, use cases, 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 Guidances.
• 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 the development of internal tools for human factors data capture, analysis, and testing.
• Contributes to identifying and developing design and development process improvements.
• 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).
• Responsibilities may include providing work direction to technicians and junior engineers.
• Collaborate with other functional groups, technical disciplines, and levels of management including other engineering disciplines such as Systems and Software Systems, UX Designers, Product Technology Leads, Marketing, Regulatory, Project Managers, Global Services, 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 4 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

• Demonstrated skills in engineering and technical leadership in the design and development of medical devices.
• Requires working knowledge of human factors, design controls, quality, 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.
• Ability to influence without authority to drive user-centered design across functional partners.
• Ability to be innovative in approaches to accomplishing user-centered design and design for usability.
• Strong technical writing skills to produce human factors protocols and reports for regulatory requirements and submissions.
• Strong problem-solving skills in diagnosing 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 at major project milestones.
• 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.

Location
Thiruvananthapuram, India

Travel
Requires travel based on business needs.

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.

• Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.

• In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue.
• We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
• We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.

• Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.

• Respect – Appreciative of others

• Integrity – Guided by our mission
• Care – Empathetic to patients
• Quality – Committed to excellence
• Creativity – Striving for innovation