Lead Human Factors Engineer, Medical Devices

TERUMO BCT, INC; Lakewood (CO); On-site; USD 109,800 - 137,200; Full time

Benefits offered by this job

401(k) plan

Wellness program

Vacation and sick time

Job summary

Terumo Blood and Cell Technologies in Lakewood, CO is seeking a Human Factors Engineer 3 to lead human factors strategy for new product development and sustainment projects. You will guide HF validation, perform user research, and collaborate with engineering, design, regulatory, and marketing teams to ensure compliant, user-centered device designs.

The role requires a minimum of four years in medical device HF, familiarity with IEC 62366 and related FDA guidance, and strong technical writing

Qualifications

• Bachelor’s degree or equivalent with focus in human factors.
• Minimum four years of experience in human factors for medical devices.
• Experience with IEC 62366, AAMI HF standards and FDA Human Factors guidance preferred.

Responsibilities

• Lead HF strategy, planning, and execution for new product development.
• Advise and approve HF impact assessments for design changes.
• Conduct user-centered research and develop use specifications and usability requirements.
• Ensure compliance with IEC 62366, AAMI HF standards and FDA guidances.
• Collaborate with cross-functional teams on UI design and risk analyses.
• Support prototype development of user interfaces and labeling.

Skills

Human factors engineering

User research

Cross-functional leadership

Regulatory awareness

Technical writing

Education

Bachelor’s degree or equivalent

B.S. in Usability/Human Factors Engineering or related

Job description

Terumo Blood and Cell Technologies in Lakewood, CO is seeking a Human Factors Engineer 3 to lead human factors strategy for new product development and sustainment projects. You will guide HF validation, perform user research, and collaborate with engineering, design, regulatory, and marketing teams to ensure compliant, user-centered device designs.

The role requires a minimum of four years in medical device HF, familiarity with IEC 62366 and related FDA guidance, and strong technical writing