Role Summary
Manager, PMO, based in Irvine, CA. Responsible for enabling successful execution of strategic projects and component/sub-assembly qualifications to support innovative healthcare products. Requires excellence in project management and end-to-end leadership to ensure projects meet quality, regulatory, and performance standards. Collaborates with Supply Chain, R&D, Quality, and Regulatory to ensure timely project transfers and effective risk mitigation.
Responsibilities
- Develops and executes project schedules and delivers key milestones and deliverables
- Develop scenario schedules with confidence levels using risk-based approaches and best practices
- Lead cross-functional core teams to facilitate seamless product transfer from project teams to manufacturing
- Manage complex projects related to process development, component qualification, and technology transfer
- Ensure thorough documentation in accordance with FpX methodologies
- Communicate project status and technical issues to the Director of Program Management, leadership, and stakeholders
- Engage with external suppliers and partners to ensure supply chain robustness
Qualifications
- Required: Minimum five (5) years of relevant professional work experience
- Required: Project management experience in regulated industries such as medical devices, healthcare, or pharmaceuticals
- Required: A minimum of two (2) years of experience managing complex projects and/or teams within a cross-functional, matrix organization
- Required: Proven experience leading cross-functional teams and complex projects
- Required: Demonstrated ability to partner, build consensus, to lead teams through influence rather than authority, and build collaborative relationships
- Required: Demonstrated success in product transfer and project execution
- Required: Strong communication, interpersonal, and leadership skills
- Required: Strong problem-solving, root cause analysis, and troubleshooting skills
- Required: Excellent written and oral communication skills. Demonstrated ability in data analytics and executive presentations
- Required: Microsoft Project (and/or other project management software)
Education
- A minimum of a Bachelorβs degree and/or equivalent University degree required
Skills
- Required: Agile Decision Making
- Required: Agility Jumps
- Required: Analytics Insights
- Required: Cross-Functional Collaboration
- Required: Expectation Management
- Required: Leadership
- Required: Organizational Project Management
- Required: Organizing
- Required: Process Improvements
- Required: Program Management
- Required: Project Management Methodology (PMM)
- Required: Project Management Office (PMO)
- Required: Project Management Tools
- Required: Project Reporting
- Required: Quality Assurance (QA)
- Required: Statement of Work (SOW)
- Required: Technical Credibility
- Preferred: Lean/Six Sigma process improvement methodologies and supply chain strategies
- Preferred: Knowledge of manufacturing processes, automation, process optimization, and complexity reduction
- Preferred: Project management certifications (PMP, FpX)
Additional Requirements
- May require up to 20% domestic and/or international travel to other locations and sites