Project Manager, Operations Job at Cordis, Irvine, CA

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  • Cordis
  • Irvine, CA

Job Description

Overview:

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.

Responsibilities:

We are seeking a highly motivated Project Manager to join our Operations and Program Management team. In this role, you will lead the Selution SLR product manufacturing expansion in Irvine, CA, managing complex construction and operational projects, coordinating cross-functional teams, and driving critical business outcomes. The ideal candidate will bring strategic insight, strong executional capabilities, and advanced experience managing resources, systems, and compliance across functional areas to align with broader organizational objectives.

 

Key Responsibilities

  • Lead the planning, execution, and governance of the Selution SLR manufacturing expansion project
  • Manage facility buildout and construction activities in collaboration with general contractors and internal stakeholders
  • Coordinate project requirements across QA, R&D, Operations, Supply Chain, and Facilities to ensure alignment and readiness
  • Develop and oversee project budgets, risk management plans, schedules and drive issue resolution
  • Ensure compliance with internal policies, GMP, and regulatory standards throughout the project lifecycle
  • Communicate project status, milestones, and risks to executive leadership and other key stakeholders
  • Apply expert-level knowledge and decision-making to resolve complex cross-disciplinary project issues
Qualifications:
  • Bachelor’s degree in Engineering, Life Sciences, or related field, or equivalent education and experience
  • 8+ years of relevant project management experience, preferably in medical device or regulated manufacturing industries
  • Demonstrated ability to lead and govern complex initiatives with accountability for operational and business results
  • Strong understanding of cross-functional interdependencies and regulatory compliance requirements (GMP, QSR)
  • Expertise in project planning, construction oversight, and capital project execution
  • Advanced project management and strategic execution skills
  • Proficiency in tools such as MS Project, Smartsheet, and related planning platforms
  • Strong communication, stakeholder engagement, and influence skills across technical and business audiences
  • Ability to analyze complex data, make informed decisions, and develop creative, compliant solutions
  • Demonstrated leadership in process ownership, budget management, and cross-functional collaboration
Preferred Qualifications:
  • PMP or related project management certification
  • Experience in facility expansion involving cleanrooms or controlled environments
  • Familiarity with ISO 13485, FDA QSR, and validation protocols

 

 

Working Conditions

  • Office-based position in Irvine, CA with frequent on-site presence in manufacturing and construction areas
  • Occasional travel to vendor sites or partner facilities as needed
  • Full-time role, standard business hours with flexibility based on project needs
  • Moderate physical activity in industrial and construction environments (e.g., walking, standing, PPE use)

 

 

Pay / Compensation
The 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.

 

Cordis 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.

Preferred Qualifications (Text Only): - PMP or related project management certification - Experience in facility expansion involving cleanrooms or controlled environments - Familiarity with ISO 13485, FDA QSR, and validation protocols     Working Conditions - Office-based position in Irvine, CA with frequent on-site presence in manufacturing and construction areas - Occasional travel to vendor sites or partner facilities as needed - Full-time role, standard business hours with flexibility based on project needs - Moderate physical activity in industrial and construction environments (e.g., walking, standing, PPE use)     Pay / Compensation The 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.       Cordis 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.

Job Tags

Full time, For contractors, Work visa,

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