Senior Scientist, Drug/Device Combo Products
Core
Hands-on device characterization and design scientist focusing on pre-filled syringe and auto injector combination product development to identify device failure risks and improvement opportunities.
Role type
Senior Scientist, Drug/Device Combo Products
Builds
Pre-filled syringe and auto injector combination product platforms
Domain
Medical devices / Drug delivery systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Mechanical engineering, Material science, Optical imaging, Mechanical testing, 3D CAD, Geometric tolerancing, FMEA, Risk-oriented development, Vendor management
Preferred skills
Design Controls (21 CFR 820.30), ISO 13485, ISO 14971, EU MDR, IEC 62304, ISO 11608, 21 CFR Part 4, 21 CFR 211
Technologies
Solidworks, X-ray computed tomography, Rheometry, Microscopy, In silico modeling
Responsibilities
Technical interrogation of drug delivery device technology platforms, Develop fundamental understanding of device material and functional properties, Facilitate design brainstorming sessions and develop proof of concepts, Liaise with QA, Analytical Sciences, and CROs, Communicate complex mechanical engineering information to cross-functional teams, Manage external vendors and manufacturers
Seniority
Senior, hands-on IC
