Senior Human Factors Engineer
Core
Lead Human Factors Engineering (HFE) and Usability Engineering (UE) planning, research, and development for Amgen drug delivery devices to ensure safe and effective use.
Role type
Senior Human Factors / Usability Engineer
Builds
Drug delivery devices, packaging, labeling, and instructions for use
Domain
Biopharmaceutical / Medical Device
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Human factors study design, usability testing, risk analysis (URRA), task analysis, regulatory compliance (FDA/IEC 62366), cross-functional collaboration, data analysis, documentation (DHF/DMR)
Preferred skills
Injectable device design, ethnographic research, prototype evaluation, virtual development environments, systems verification and validation
Technologies
IEC 62366, AAMI HE75, EN 60601-1-6, ISO 14971, MDR
Responsibilities
Lead HFE/UE activities to improve device-user interface design; Analyze usability study data to inform product design and mitigate use-risk; Create documentation for regulatory submissions and design controls; Partner with engineering, regulatory, and clinical teams to ensure product safety; Conduct formative and summative human factors studies.
Seniority
Senior, hands-on IC
