Human Factors Engineer II — Usability for Medical Devices

Terumo Blood and Cell Technologies; Lakewood (CO); On-site; USD 86,400 - 108,000; Full time

Benefits offered by this job

401(k) matching

Vacation and sick time

Medical/dental/vision plans

Job summary

Terumo Blood and Cell Technologies in Lakewood, CO, seeks an Engineer 2 - Human Factors to perform independent human factors research, analyses, and evaluation under supervision to support user-centered product design and development.

The role emphasizes risk analyses, usability studies, cross-functional collaboration, and adherence to IEC 62366, AAMI HE75, and FDA guidelines, with a BS and 2+ years of HF experience preferred.

Qualifications

• Bachelor’s degree in Usability/Human Factors, Biomedical Engineering, Systems Engineering or related field.
• Minimum 2 years experience in Human Factors/usability for medical devices and familiarity with IEC/ FDA guidance.
• Experience with risk management activities (URA, UFMEA, AFMEA, UEA) preferred.

Responsibilities

• Supports HF activities for new product development and sustaining projects impacting the user interface.
• Advises, reviews, and approves HF impact assessments for product design changes.
• Conducts user-centered research including interviews, contextual inquiries, and usability evaluations.
• Performs usability testing and data analysis to inform design decisions.
• Collaborates with cross-functional teams to define use-related risks and UI requirements.
• Supports development of internal HF tools, protocols, and reports for regulatory submissions.

Skills

Human factors

Usability testing

Cross-functional collaboration

Regulatory compliance

Design controls

Project management

Technical writing

Prototyping tools

Education

Bachelor's degree in Usability/Human Factors Engineering

BS in Biomedical Engineering or Systems Engineering or related

Tools

GUI design tools (Figma)

Job description

Terumo Blood and Cell Technologies in Lakewood, CO, seeks an Engineer 2 - Human Factors to perform independent human factors research, analyses, and evaluation under supervision to support user-centered product design and development.

The role emphasizes risk analyses, usability studies, cross-functional collaboration, and adherence to IEC 62366, AAMI HE75, and FDA guidelines, with a BS and 2+ years of HF experience preferred.