Associate Director, Device Engineering

CSL Plasma Inc.; Bern; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Benefits dieser Stelle

Restaurant perks

Zusammenfassung

CSL Behring is seeking an Associate Director of Device Engineering in its DDSP organization. The role leads the device engineering team, driving drug–device combination product development, risk management, and program-level integration with CMC and product strategy.

The ideal candidate has 10+ years in pharma/med device, strong leadership, and excellent communication within a matrix environment. International travel up to 20% is expected.

Qualifikationen

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

Aufgaben

• Lead the Device Engineering team for drug–device combination product development across assets, coordinating inputs from multiple functions.
• Mentor team members and coordinate device development activities including inputs, outputs, verification/validation planning, supplier qualification, and regulatory submission support.
• Own and maintain the Design History File (DHF) and ensure documentation is complete, inspection-ready, and compliant with CSL quality system and regulatory frameworks.
• Translate user needs and program strategy into product requirements, development plans, milestones, risks, and deliverables.
• Lead risk management activities and plan/implement combination product control strategies across supply.
• Represent device engineering on cross-functional program teams and ensure deliverables align with program needs.

Kenntnisse

Cross-functional leadership

Risk management

Program management

Ausbildung

Science or Engineering degree

Jobbeschreibung

The 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. 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 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 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 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 world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

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 https://www.csl.com/careers/inclusion-and-belonging

Equal 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 https://www.csl.com/accessibility-statement. 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 click here. CSL Global Privacy Notice for Job Applicants and Candidates