Associate Director, Device Engineering

Full-time CAR

The Associate Director of Device Engineering is a leadership position in the Drug Delivery Systems & Packaging (DDSP) department within CSL’s Technical Operations. This role will report to the Director of Design Assurance.

The ideal candidate has a solid track record in the development of drug delivery devices, from concept development through commercialization and product maintenance, i.e., sustaining. The Associate Director of Device Engineering provides combination-product leadership and ensures that device-related development plans and evidence packages are integrated into the overall CMC and product strategy. The role requires strong cross-functional and external partner leadership, engineering team management, and stakeholder management.

Responsibilities

Lead the Device Engineering team for drug–device combination product development across assigned assets, coordinating cross-functional inputs from Device Engineering, Human Factors, Quality, Regul...