Director, Device User Interface
Core
Lead a team to translate user needs into robust design inputs and execute end-to-end Human Factors activities for medical devices and drug-device combination products.
Role type
Senior IC Director, Human Factors Engineering (Medical Devices)
Builds
Medical devices, drug delivery systems, and combination products
Domain
Healthcare / Medical Devices / Drug Delivery
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Human Factors Engineering, Usability Engineering, Risk Management (ISO 14971), Regulatory Strategy (FDA/EMA), Team Leadership, Project Management, Drug Delivery Technologies, Design Control, Stakeholder Management
Preferred skills
MSc/PhD/MBA, NCE and Generic product development experience, Submission/filing experience for regulatory agencies, Medical Device design control activities
Technologies
ISO 13485, ISO 62366, 21CFR Part 820, EU MDR
Responsibilities
Lead team in translation of user needs to design inputs; Guide execution of Human Factors activities from formative to summative studies; Mentor team in usability engineering and regulatory strategy; Ensure portfolio alignment on CUHF studies for ANDA submissions; Drive user risk management compliance; Partner cross-functionally with Device Design, Clinical, and Regulatory Affairs; Oversee external vendors for study execution.
Seniority
Director, hands-on leadership
