Associate Director, Device Engineering

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.ResponsibilitiesLead the Device Engineering team for drug–device combination product development across assigned assets, coordinating cross-functional inputs from Device Engineering, Human Factors, Quality, Regulatory, Clinical/Medical, Procurement, Manufacturing/Technical Operations, Supply Chain, Commercial, and external partners.Support and mentor Device Engineering team members, developing technical and leadership skills.Lead and coordinate device selection and development activities appropriate to the development stage, including inputs, outputs, verification and validation planning, supplier qualification, test strategy, documentation readiness, and regulatory submission support. Own and maintain the Design History File (DHF), ensuring documentation is complete, accurate, inspection-ready, and compliant with the CSL quality system and applicable regulatory frameworks for combination products.Translate user needs and program strategy into product requirements, development plans, milestones, risks, and deliverables. Ensure alignment between device design, Primary Packaging, Secondary Packaging, Human Factors, and overall CMC/product strategy.Lead risk management activities, including hazard analysis, risk assessments, and mitigation planning. Plan and implement combination product control strategy across supply in alignment with CMC. Support human factors and usability activities to ensure the user interface, instructional materials, and intended-use considerations align with patient needs and regulatory expectations. Set and drive best practices within DDSP for Device Engineering, including standardized approaches for design risk assessment, biological evaluation, and other key deliverables.Represent the device engineering team on cross-functional program teams and ensure combination product deliverables are aligned with program needs. Create, manage, and execute integrated workplans, timelines, decision logs, meeting cadences, risk registers, and escalation pathways. Partner with project leads and development teams to ensure clear priorities, timely execution, and effective resolution of risks and dependencies.Establish and maintain strong working relationships with suppliers, vendors, OEMs, test...