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

Competitive compensation

401(k) with match

Vacation and Sick time

Job summary

Terumo Blood and Cell Technologies in Colorado is seeking an Engineer 3 - Human Factors to apply user-centered design, conduct HF research, and support new product development and sustaining projects.

You will lead HF activities, perform usability testing, ensure IEC/AAMI/FDA compliance, collaborate with cross-functional teams, and contribute to risk analyses and design controls. Domestic travel may be required.

Qualifications

• Bachelor's degree or equivalent in Usability/Human Factors Engineering, Biomedical Engineering, Systems Engineering or related field.
• Experience with Human Factors/Usability in medical devices and familiarity with IEC AAMI FDA guidance preferred.

Responsibilities

• Leads HF strategy, planning, and execution for new product development and sustaining projects.
• Reviews HF impact assessments for product design changes.
• Conducts user-centered research including interviews and task analyses for use specifications and usability requirements.
• Performs usability testing throughout development from prototyping to validation.

Skills

Engineering leadership

Human factors

Regulatory knowledge

Communication skills

Project management

Cross-functional collaboration

Mentoring

Usability studies

Design controls

Risk management

Technical writing

Education

BS in Usability/Human Factors

Biomedical/Systems Engineering

Job description

Terumo Blood and Cell Technologies in Colorado is seeking an Engineer 3 - Human Factors to apply user-centered design, conduct HF research, and support new product development and sustaining projects.

You will lead HF activities, perform usability testing, ensure IEC/AAMI/FDA compliance, collaborate with cross-functional teams, and contribute to risk analyses and design controls. Domestic travel may be required.