Associate Director, Device Engineering

CSL Behring Vifor seeks an Associate Director for Device Engineering to lead drug-device combination product development, ensuring regulatory compliance and strategic integration within Technical Operations.

This leadership role sits within the Drug Delivery Systems & Packaging department under CSL’s Technical Operations, reporting directly to the Director of Design Assurance. The position provides strategic oversight for combination products, ensuring that device-related development plans and evidence packages are seamlessly integrated into the broader CMC and product strategy.

Responsibilities

• Direct the Device Engineering team in the development of drug-device combination products, managing cross-functional coordination.
• Mentor team members to enhance both their technical expertise and leadership capabilities.
• Oversee device selection and development processes tailored to the specific stage of the product lifecycle.
• Manage the Design History File (DHF), ensuring all documentation is accurate, complete, and ready for regulatory inspections.
• Convert user needs and program strategies into clear product requirements, milestones, risk assessments, and deliverables.
• Lead risk management efforts, including hazard analysis and mitigation planning.
• Support human factors and usability studies to align user interfaces and instructional materials with patient needs and regulatory standards.
• Develop and execute integrated workplans, timelines, decision logs, and escalation pathways.
• Build and maintain relationships with external partners, including suppliers, vendors, OEMs, testing laboratories, and contract manufacturing organizations.
• Implement end-to-end capabilities for drug-device combination development within the Drug Product Development division.
• Drive innovation by scouting and evaluating new technologies.
• Represent the company in industry forums, such as ISO technical committees and BioPhorum.

Requirements

• Minimum of 10 years of experience in the pharmaceutical or medical device sector.
• Deep subject matter expertise in medical device development, particularly with drug-device combination products.
• Strong communication skills with a proven ability to thrive in matrix environments.
• Capacity to influence stakeholders and foster a culture of continuous improvement.
• A relevant academic degree in Science or Engineering.

What the company offers

• Details regarding CSL benefits can be found on the company website.

About the company

CSL Behring is a global leader in biotherapeutics, dedicated to saving lives through innovative therapies. The company leverages three core scientific platforms: plasma fractionation, recombinant protein technology, and cell and gene therapy. With a workforce of 32,000 employees, CSL delivers lifesaving treatments to patients in over 100 countries, driven by a mission centered on inclusion, belonging, curiosity, and empathy.

• Global biotherapeutics leader focused on saving lives.
• Commitment to serving patient needs through innovative technologies.
• Core values of inclusion and belonging fuel innovation.
• Operates across plasma fractionation, recombinant protein, and cell and gene therapy platforms.
• Employs 32,000 people and serves patients in more than 100 countries.