Associate Director, Device Engineering

Das ist der Job

Plan and implement combination product control strategy across supply in alignment with CMC.

Darum lohnt es sich

The role requires strong cross-functional and external partner leadership, engineering team management, and stakeholder management. /ppbResponsibilities /b /pliLead 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. /liliSupport and mentor Device Engineering team members, developing technical and leadership skills. /liliLead 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.

Set and drive best practices within DDSP for Device Engineering, including standardized approaches for design risk assessment, biological evaluation, and other key deliverables. /liliRepresent the device engineering team on cross-functional program teams and ensure combination product deliverables are aligned with program needs.

Partner with project leads and development teams to ensure clear priorities, timely execution, and effective resolution of risks and dependencies. /liliEstablish and maintain strong working relationships with suppliers, vendors, OEMs, testing labs, CMOs, and other external partners to enable development, qualification, and submission-supporting activities.

Mentor Device Engineers, promote consistency across programs, monitor industry trends, standards, and regulatory guidance. /lipbEducation Requirements /b /ppRelevant academic qualification in an appropriate field, e.g., a suitable Science or Engineering degree. /ppbExperience Requirements /b /pliAt least 10 years of related experience in the pharmaceutical or medical device industry. /liliSubject Matter Expertise on medical device development with a preference for drug-device combination product development and sustaining. /liliExcellent communication skills and a track record working in a matrix environment. /liliAbility to influence and promote a culture of continuous improvement. /lipThe role requires an ability to travel internationally up to 20%. /pppbbAbout CSL Behring /b /b /p /ppCSL Behring is a global biotherapeutics leader driven by our promise to save lives.

Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. /ppTo learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at . /ppbOur Benefits /b /p pThe 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. /ppThe 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.

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. /liliTranslate 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. /liliLead risk management activities, including hazard analysis, risk assessments, and mitigation planning.

Support human factors and usability activities to ensure the user interface, instructional materials, and intended-use considerations align with patient needs and regulatory expectations. Create, manage, and execute integrated workplans, timelines, decision logs, meeting cadences, risk registers, and escalation pathways.

Support sourcing strategy, due diligence, and business development assessments related to combination products within the scope of technical expertise. /liliImplement 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 as well as sharing information from industry forums back to CSL colleagues. /liliOwn program-level tracking of timelines, risks, decisions, and deliverables to communicate progress clearly.

Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.

We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. /ppbr/CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma.