Director, Regional Device & Drug Delivery Center of Excellence (RTC)
Core
Lead the design, assembly, validation, and regulatory strategy for drug delivery devices (autoinjectors, pens) and container closure systems for biopharma clients.
Role type
Senior IC Director of Device Engineering & Center of Excellence
Builds
Drug delivery devices, container closure systems, and automated assembly/test processes
Domain
Medical Devices / Drug Delivery / Biopharma
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Device design (autoinjector/pen/needle safety), ISO 14971 risk management, 510(k) regulatory strategy, root-cause analysis (CT/X-ray/imaging), automation strategy, DFM, ISO 11608/11040 standards, team leadership, client-facing technical communication
Preferred skills
Device platform partnerships, statistical process control, multi-program portfolio management
Technologies
CT scan, X-ray imaging, high-speed cameras, metrology equipment, automation tooling
Responsibilities
Lead translation of user needs into device strategy; own label/packaging design and DFM; direct device assembly/test process design from concept to DV; define automation strategy; establish in-process controls and metrology; drive validation philosophy; lead cross-functional RCA investigations; represent the center in client-facing technical discussions and proposal development
Seniority
Director, strategic leadership with hands-on technical expertise
