Engineer- Human Factors Engineer / Usability Engineer (HF/ UE)
Core
Design and validate drug delivery devices and combination products to ensure safety, usability, and regulatory compliance for patients with serious illnesses.
Role type
Human Factors Engineer / Usability Engineer (HFE/UE)
Builds
Drug delivery devices, packaging, labeling, and instructions for use for oncology, inflammation, general medicine, and rare disease treatments.
Domain
Biotechnology / Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Human factors engineering, usability engineering, study design and moderation, data analysis, risk assessment, task analysis, regulatory standards knowledge (FDA, IEC 62366, ISO 14971), design controls documentation
Preferred skills
Ethnographic research, contextual inquiries, focus groups, device UI evaluation, low and high-fidelity prototyping, virtual development environments, mechanical/electrical/software/clinical/regulatory/safety/risk/quality engineering collaboration
Technologies
IEC 62366, AAMI HE75, EN 60601, ISO 14971, MDR, design controls
Responsibilities
Support HFE/UE planning, research, development, and continuous improvement of drug delivery devices; collaborate with cross-functional teams to translate user requirements into product UI requirements; manage usability studies including protocol development, participant recruitment, and data analysis; prepare documentation for design history files, design risk management files, and regulatory submissions; analyze objective and subjective data to inform design and risk minimization; communicate with internal and external stakeholders.
Seniority
Mid-level to Senior, hands-on IC
