Associate Director, Device Engineering
On-siteKongens Lyngby, Capital Region, Denmark
Job Summary
Lead the Device Engineering team for drug–device combination product development, coordinating cross-functional inputs from Quality, Regulatory, Clinical, and Manufacturing. Support and mentor team members while driving device selection, verification, validation planning, and regulatory submission support. Own the Design History File to ensure documentation is complete, accurate, and compliant with regulatory frameworks. Translate user needs into product requirements and lead risk management activities including hazard analysis and mitigation planning. Establish best practices for design risk assessment and biological evaluation, while representing CSL in industry forums like ISO TCs and BioPhorum. Manage integrated workplans, timelines, and decision logs to ensure timely execution and effective risk resolution. Travel internationally up to 20% to support supplier qualification, testing, and global program alignment.
Required Qualifications
- Relevant academic qualification in an appropriate field, e.g., a suitable Science or Engineering degree
- At least 10 years of related experience in the pharmaceutical or medical device industry
- Subject Matter Expertise on medical device development
- Preference for drug-device combination product development and sustaining
- Excellent communication skills
- Track record working in a matrix environment
- Ability to influence and promote a culture of continuous improvement
- Ability to travel internationally up to 20%
Desired Qualifications
- Ability to effectively lead and coach others
- Ability to translate user needs and program strategy into product requirements, development plans, milestones, risks, and deliverables
- Ability to ensure alignment between device design, Primary Packaging, Secondary Packaging, Human Factors, and overall CMC/product strategy
- Ability to lead risk management activities, including hazard analysis, risk assessments, and mitigation planning
- Ability to plan and implement combination product control strategy across supply in alignment with CMC
- Ability to support human factors and usability activities to ensure the user interface, instructional materials, and intended-use considerations align with patient needs and regulatory expectations
- Ability to set and drive best practices within DDSP for Device Engineering, including standardized approaches for design risk assessment, biological evaluation, and other key deliverables
- Ability to represent the device engineering team on cross-functional program teams and ensure combination product deliverables are aligned with program needs
- Ability to create, manage, and execute integrated workplans, timelines, decision logs, meeting cadences, risk registers, and escalation pathways
- Ability to 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
- Ability to support sourcing strategy, due diligence, and business development assessments related to combination products within the scope of technical expertise
- Ability to 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
- Ability to drive innovation through technology scouting and evaluation, identifying opportunities to improve patient experience, manufacturability, robustness, and lifecycle flexibility
- Ability to represent CSL interests in industry forums such as ISO TCs and BioPhorum as well as sharing information from industry forums back to CSL colleagues
- Ability to own program-level tracking of timelines, risks, decisions, and deliverables to communicate progress clearly
- Ability to mentor Device Engineers, promote consistency across programs, monitor industry trends, standards, and regulatory guidance
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