Project Manager – Operations (Manufacturing Expansion)
About The Position
Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs. We are seeking an experienced and driven Project Manager to lead and coordinate the Selution SLR product manufacturing expansion in Irvine, CA. This role will oversee cross-functional project execution, manage construction and facility build-out activities with external general contractors, and ensure alignment across internal stakeholders including Quality Assurance (QA), Research & Development (R&D), Operations, Supply Chain, and Facilities. The ideal candidate will have a proven track record of managing complex technical projects in regulated environments, preferably in the medical device or life sciences industry.
Requirements
- Bachelor’s degree in Engineering, Business, or related technical discipline.
- 8+ years of experience in operations, manufacturing, or project management.
- Strong understanding of manufacturing processes, planning, and quality systems.
- Demonstrated ability to manage complex, cross-functional projects.
- Excellent organization, analytical, and communication skills.
- Experience managing construction projects involving cleanrooms, labs, or GMP environments.
- Strong background working cross-functionally with QA, R&D, and Supply Chain teams.
Nice To Haves
- Experience in launching or expanding medical device manufacturing operations.
- Familiarity with ISO 13485, FDA QSR, and cleanroom standards.
- Experience managing CAPEX projects >$5M.
Responsibilities
- Lead end-to-end planning and execution of the Selution SLR manufacturing expansion project.
- Develop detailed project schedules, budgets, and resource plans in collaboration with stakeholders.
- Track project progress, manage risks, and drive issue resolution to ensure on-time and within-budget delivery.
- Serve as primary point of contact for general contractors, architects, and construction managers.
- Coordinate facility design reviews and construction timelines to ensure operational readiness.
- Ensure compliance with building codes, EH&S, and GMP standards.
- Collaborate with cross-functional teams including QA, R&D, Operations, Supply Chain, and Facilities to define project requirements and deliverables.
- Facilitate communication between engineering, quality, and production teams to ensure design transfer and operational readiness.
- Manage external vendors, consultants, and service providers; negotiate contracts and monitor performance.
- Maintain alignment with internal and external stakeholders on scope, schedule, and expectations.
- Provide regular updates to executive leadership and project steering committees.
- Maintain accurate project documentation, including risk registers, meeting minutes, and change orders.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
