Associate Director, Device Engineering

The Associate Director, Device Engineering joins CSL's Technical Operations within the Drug Delivery Systems & Packaging (DDSP) division. Reporting to the Director of Design Assurance, this senior role steers the creation and upkeep of drug‑device combination products, aligning engineering output with the broader CMC and product roadmap. Day‑to‑day, the incumbent directs a multidisciplinary team that spans device design, human factors, quality, regulatory, clinical, procurement, manufacturing, supply chain and commercial groups, as well as external collaborators. Core duties include guiding device selection, planning verification and validation, qualifying suppliers, shaping test strategies, preparing documentation for regulatory filings, and maintaining a complete Design History File. The leader also translates user insights and program goals into clear product requirements, risk assessments, milestones and deliverables, while fostering best‑practice standards across the DDSP unit. The position demands a solid academic background in a scientific or engineering discipline and at least a decade of experience in the pharmaceutical or medical‑device arena. Candidates must possess deep expertise in medical‑device development, particularly for combination products, and demonstrate outstanding communication skills within a matrix‑style organization. The ability to influence stakeholders, champion a culture of continuous improvement, and travel internationally up to twenty percent of the time are essential. Working at CSL offers exposure to a global network of suppliers, OEMs, testing laboratories and contract manufacturers, providing ample opportunities to shape sourcing strategies and drive technology scouting initiatives. The role contributes to industry forums such as ISO technical committees and BioPhorum, ensuring the company stays at the forefront of regulatory and scientific advances. The team environment emphasizes mentorship, knowledge sharing and the establishment of reusable playbooks and templates to streamline future projects. What the role asks for: - Relevant Science or Engineering degree - Minimum 10 years in pharma or medical device field - Expertise in medical device development, especially combination products - Strong communication abilities in a matrix organization - Ability to influence and drive continuous‑improvement culture - Willingness to travel internationally up to 20 % - Preference for experience in drug‑device combination product sustaining