Associate Director, Device Engineering

The Associate Director of Device Engineering is a leadership position within the Drug Delivery Systems & Packaging (DDSP) department at CSL's Technical Operations. This role provides combination-product leadership and ensures device-related development plans and evidence packages are integrated into the overall CMC and product strategy.

• Lead 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, testing labs, CMOs, and other external partners to enable development, qualification, and submission-supporting activities.
• Support sourcing strategy, due diligence, and business development assessments related to combination products within the scope of technical expertise.
• Implement and approve end-to-end capabilities for drug–device combination development within Drug Product Development, including playbooks, templates, best practices, and knowledge-sharing approaches.
• Drive innovation through technology scouting and evaluation, identifying opportunities to improve patient experience, manufacturability, robustness, and lifecycle flexibility.
• Represent CSL interests in industry forums such as ISO TCs and BioPhorum and share information from industry forums with CSL colleagues.
• Own program-level tracking of timelines, risks, decisions, and deliverables to communicate progress clearly.
• Mentor Device Engineers, promote consistency across programs, monitor industry trends, standards, and regulatory guidance.