Project Manager - Medical Device Manufacturing Expansion

OverviewSelution, 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.ResponsibilitiesWe 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.Key ResponsibilitiesProject Planning & ExecutionLead 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.Construction & Facility ExpansionServe 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.Cross-functional CoordinationCollaborate 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.Stakeholder & Vendor ManagementManage external vendors, consultants, and service providers; negotiate contracts and monitor performance.Maintain alignment with internal and external stakeholders on scope, schedule, and expectations.Reporting & DocumentationProvide regular updates to executive leadership and project steering committees.Maintain accurate project documentation, including risk registers, meeting minutes, and change orders.QualificationsRequired Qualifications: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.Preferred Qualifications:Experience in launching or expanding medical device manufacturing operations.Familiarity with ISO 13485, FDA QSR, and cleanroom standards.Experience managing CAPEX projects >$5M.Key CompetenciesExcellent project management, budgeting, and scheduling skills.Strong leadership and communication skills; able to work effectively with executive and technical stakeholders.Proficient in project management tools such as MS Project, Smartsheet, or equivalent.Working ConditionsBased in Irvine, CA with occasional travel to other sites or vendor locations.Primarily office and site-based work, with frequent visits to construction and production areas.Must comply with all EHS and GMP policies.Pay / CompensationThe expected pre-tax pay rate for this position is $111,650 - $159,500 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.Preferred QualificationsCordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one's identity. All our teammates' points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.JOIN OUR TALENT COMMUNITYJoining our Talent Community is a great way to receive company news and updates, as well notifications on career opportunities and events that interest you! Please tell us more about yourself so we can align you with future opportunities that match your background, skills and interests.Job LocationsUS-CA-IrvineID2026-12522CategoryOperationsPosition TypeRegular Full-TimeCORDIS is proud to be an equal opportunity employer, values diversity in all its forms is and committed to fostering an inclusive work environment. We are committed to advancing our culture of belonging, where all teammates feel seen, heard, and appreciated and encouraged to be their authentic selves. Our team is invested in attracting, retaining and growing top talent. Our Teammates are the core of our innovation and success. Cordis is an inclusive, engaging place to work and grow a career. CORDIS is committed to offering reasonable accommodations, upon request, to job applicants with disabilities. If you need assistance or an accommodation due to a disability, please contact GlobalHR@Cordis.com