FREE ACCESS
5,000–10,000 jobs/day
See all jobs on JobTailor
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in drug-device combination product development, including risk management, regulatory compliance, and cross-functional collaboration. Proven ability to lead teams, mentor engineers, and drive innovation in the pharmaceutical and medical device sectors.
Highest-signal resume keywords
Drug-Device Combination Product DevelopmentRegulatory ComplianceRisk ManagementCross-Functional Team LeadershipSubject Matter Expertise in Medical Device Development
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Design History File ManagementVerification and Validation PlanningSupplier QualificationTest Strategy DevelopmentDocumentation Readiness
Soft Skills
Excellent Communication SkillsAbility to InfluenceMentoring and Coaching
Tools & Technologies
Integrated WorkplansRisk RegistersDecision Logs
Industry Keywords
Pharmaceutical IndustryMedical Device IndustryHuman FactorsContinuous ImprovementISO Standards
About the role
Key responsibilities & impact- 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.
Requirements
What you’ll need- 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 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%.
Benefits
Comp & perks- For more information on CSL benefits visit How CSL Supports Your Well-being | CSL