Validation Engineer Biomedical Jobs in Colorado (NOW HIRING)

Requisition ID:  35316  

At Terumo Blood and Cell Technologies, our 8,000+ global associates proud to 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 continuing to increase the number of patients we serve. Advancing healthcare with heart.

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. Join us and help shape wherever we go next. You create your future and ours.

Engineer 2 - Human Factors

JOB SUMMARY

Work requires independent human factors research, analysis, and evaluation using standard human factors engineering (HFE) theories, principles, and data under advisement of a senior engineer to facilitate user-centered product design and development.  Assignments include applying HFE to system user interface definition, design, and evaluation for new product development, as well as for sustaining and innovation projects.  Duties are assigned to provide experience and familiarization with engineering methods, independent thinking, leadership opportunities, and company practices and policies.

ESSENTIAL DUTIES

• 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).

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, 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 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. 

-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 domestic and international travel based on business needs.

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
Target Bonus on Base:  7.0%

We anticipate this requisition will be open for a minimum of five days, from    . We encourage your prompt application.

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.

• Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
• In 2024, Terumo Blood and Cell Technologies reached $1.5 billion in revenue.
• We employ nearly 8,000 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
• We contribute to the Leukemia and Lymphoma Society (LLS), raising $2.4 million USD since 2025.

We are proud to be an Equal Opportunity Affirmative Action Employer.  All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.

Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment. Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.