Human Factors Engineer II — Medical Devices

Terumo BCT, Inc.; Lakewood (CO); On-site; USD 86,400 - 108,000; Full time

Benefits offered by this job

Medical benefits

Dental and vision plans

401(k) plan with matching

Vacation and sick time

Job summary

Terumo Blood and Cell Technologies in Colorado is seeking an Engineer 2 - Human Factors to lead and assist human factors activities for new product development and sustaining projects. This role focuses on user interface design, usability testing, and regulatory-compliant HF documentation.

You will work with cross-functional teams to define use profiles, perform context interviews, and develop HF requirements, while applying IEC, AAMI, and FDA guidance to ensure patient-centered design and

Qualifications

• Minimum 2 years experience in human factors/usability for medical devices.
• Experience with IEC Usability standards, AAMI Human Factors standards, or FDA Human Factors Guidance preferred.
• Experience with risk management activities (URA, UFMEA, AFMEA, UEA) preferred.

Responsibilities

• Support HF activities for new product development and sustaining projects affecting user interfaces.
• Advise and approve HF impact assessments for design changes.
• Conduct user-centered research including interviews and usability testing.
• Collaborate with cross-functional teams to define use profiles and interface requirements.
• Develop and maintain usability protocols and reports for regulatory submissions.

Skills

Human factors

Usability engineering

Design controls

Risk management

Cross-functional collaboration

Project management

Communication

Leadership

Prototyping tools

Education

Bachelor's degree in Usability/Human Factors Engineering

BS in Usability/Human Factors Engineering or related field

Tools

Figma

Job description

Terumo Blood and Cell Technologies in Colorado is seeking an Engineer 2 - Human Factors to lead and assist human factors activities for new product development and sustaining projects. This role focuses on user interface design, usability testing, and regulatory-compliant HF documentation.

You will work with cross-functional teams to define use profiles, perform context interviews, and develop HF requirements, while applying IEC, AAMI, and FDA guidance to ensure patient-centered design and