Lead Human Factors Engineer – Medical Devices

Amgen Inc.; Thousand Oaks (CA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental & vision coverage

Stock-based incentives

Flexible time-off & leave policies

Job summary

Amgen Inc. is seeking a Senior Human Factors Engineer to lead HF/UE planning, research, and development for drug delivery devices. You will collaborate across functions to ensure safe and effective device interfaces and contribute to regulatory submissions.

You will design and execute usability studies, analyze results, and create documentation to support design controls and DHF/DMR. Domestic travel up to 20% is possible.

Qualifications

• Doctorate degree required in a relevant field with strong HF/UE expertise.
• Experience in Biomedical/Pharmaceutical/Medical Device environments preferred.
• Knowledge of FDA/HF guidance, IEC 62366, ISO 14971 is expected.

Responsibilities

• Lead HF/UE planning, research, development, and continuous improvement of drug delivery devices.
• Conduct formative and summative usability studies with robust analysis.
• Prepare regulatory submissions and HF documentation (URRA, usability reports).
• Collaborate cross-functionally with engineering, risk, quality, clinical, and regulatory teams.

Skills

Human factors engineering

Usability testing

Cross-functional collaboration

Regulatory awareness

Education

Doctorate in relevant field

Master’s in Human Factors/Usability Engineering

Bachelor’s in related field

Associate’s degree in related field

High school diploma / GED

Job description

Amgen Inc. is seeking a Senior Human Factors Engineer to lead HF/UE planning, research, and development for drug delivery devices. You will collaborate across functions to ensure safe and effective device interfaces and contribute to regulatory submissions.

You will design and execute usability studies, analyze results, and create documentation to support design controls and DHF/DMR. Domestic travel up to 20% is possible.