Senior Device Design Engineer
Core
Lead assigned programs within the DDI portfolio stream for complex injectables and combination products, managing end-to-end device design, documentation, and regulatory submissions.
Role type
Senior Device Design Engineer (Medical Devices/Combination Products)
Builds
Medical devices, combination products (drug-delivery systems), and associated packaging/labeling for respiratory, biologic, biosimilar, and injectable products.
Domain
Healthcare / Medical Device Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CAD design (SolidWorks, Creo), GD&T, tolerance stack-up analysis, FEA, CFD, root cause analysis, risk management (FMEA, FTA), ISO 13485 QMS, ISO 14971 risk management, plastic injection moulding design
Preferred skills
Project management training, Lean Six Sigma accreditation, experience with design transfer
Technologies
SolidWorks, Creo, CAD, FEA, CFD
Responsibilities
Drive "right first time" approach to high-quality DHF documentation and submission packages; maintain compliance with QMS and procedural standards; lead development of combination products from concept to design transfer; represent the function in cross-functional program teams; generate and approve technical documentation including drawings, specifications, and risk management files.
Seniority
Senior, hands-on IC