Senior Principal Engineer, Human Factors
Core
Lead Human Factors Engineering for drug delivery devices, focusing on user interface development, instructional materials, and regulatory submissions to ensure patient needs are met.
Role type
Senior Principal Human Factors Engineer (Drug Delivery Systems)
Builds
User interfaces, Instructions for Use, secondary packaging, and regulatory dossiers for drug delivery devices.
Domain
Pharmaceutical / Medical Devices / Human Factors Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Human Factors Engineering (HFE), Task Analysis, Use Risk Assessment, IEC 62366 standards, user interface evaluation, instructional material development, regulatory dossier preparation, CRO oversight, data analysis for regulatory submissions
Preferred skills
Ergonomics, Psychology, Science or Engineering background
Technologies
None explicitly stated
Responsibilities
Plan and execute Human Factors Engineering activities including formative and summative evaluations; Lead development of selection criteria and evaluation of user interfaces; Collect and utilize data on user capabilities and use problems; Contribute to Company Core Data Sheets; Monitor industry trends, standards, and regulatory guidance
Seniority
Senior, hands-on IC with strategic oversight