Associate Director, Device Engineering

The Associate Director of Device Engineering is a leadership position in the Drug Delivery Systems & Packaging (DDSP) department within CSLs 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 drugdevice 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 drugdevice 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.
• 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.

Education Requirements

Relevant academic qualification in an appropriate field e.g. a suitable Science or Engineering degree.

Experience Requirements

• At least 10 years of related experience in the pharmaceutical or medical device industry.
• Subject Matter Expertise on medical device development with a preference for drug-device combination product development and sustaining.
• Excellent communication skills and a track record working in a matrix environment.
• Ability to influence and promote a culture of continuous improvement.

The role requires an ability to travel internationally up to 20%.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. 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.

CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL CSL Behring CSL Seqirus and CSL Vifor visit and CSL Plasma at Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being CSL.

You Belong at CSL

At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process please visit Experience:

Director