Lead Human Factors Engineer - Medical Device UX

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

Benefits offered by this job

Competitive benefits

Stock-based incentives

Flexible work models

Job summary

Amgen is seeking a Senior Human Factors Engineer to lead HF/UE planning, research, and development of drug delivery devices. The role partners with engineering, risk, quality, regulatory, clinical, and manufacturing teams to ensure safe and intuitive product interfaces and compliant documentation.

Responsibilities include designing and executing usability studies, informing device/UI design through data analysis, and supporting clinical studies and regulatory submissions with HF expertise.

Qualifications

• Doctorate or equivalent degree in a relevant field.
• Experience in Biomedical/Pharmaceutical/Medical Device field.
• Strong knowledge of HF/UE methodologies.
• Experience with FDA guidance and ISO standards.

Responsibilities

• Lead HF/UE planning, research, and development activities.
• Coordinate and conduct formative and summative usability studies.
• Collaborate with engineering, risk, quality, regulatory and clinical teams.
• Create documentation: DHF, DMR, URRA, usability assessments.
• Support regulatory submissions with HF expertise.
• Communicate regularly with internal and external partners.

Skills

Human Factors Engineering

Usability Engineering

Regulatory knowledge

Risk assessment

User research

Education

Doctorate

Master's

Bachelor's

Associate's

High school diploma

Job description

Amgen is seeking a Senior Human Factors Engineer to lead HF/UE planning, research, and development of drug delivery devices. The role partners with engineering, risk, quality, regulatory, clinical, and manufacturing teams to ensure safe and intuitive product interfaces and compliant documentation.

Responsibilities include designing and executing usability studies, informing device/UI design through data analysis, and supporting clinical studies and regulatory submissions with HF expertise.