Project Manager (Irvine)

Location : Irvine, CA (Hybrid) Rate : $50-55 / hr on W-2 (NO C2C) Type : Contract Overview We are seeking a Manager, Project / Program Management to successfully lead project and program teams through all stages of product development, clinical evaluations, operational readiness, and commercialization. This role is critical in ensuring new and improved products and related accessories meet best-in-class quality standards while delivering on-time commercialization aligned with business objectives. Key Responsibilities Lead large-scale projects / programs, ensuring strict adherence to Quality Systems and Change Control processes. Develop and manage program business cases, budgets, schedules, and resource allocation. Facilitate creation and execution of program strategies across quality assurance, risk management, communications, and staffing. Manage program status reporting, stakeholder updates, and accurate program data. Lead and mentor project / program management peers and team members. Facilitate team meetings, improve decision-making processes, and monitor workflows. Foster a culture of urgency, accountability, and transparent communication across project teams. Resolve complex challenges and drive teams toward effective outcomes. Build and maintain positive stakeholder relationships across a matrixed organization. Required Experience & Skills 6+ years of direct experience managing new product development (NPD) projects of increasing complexity. Proven track record in the medical device industry, including projects that involve software, firmware, thermoplastic hardware, and disposables. Proficient in medical device regulations and product development processes. Strong background in program / project management methodologies, MS Office, and related project management tools. Exceptional problem-solving, analytical, and decision-making skills. Ability to work effectively across complex organizations and influence stakeholders at all levels. Preferred Qualifications Experience in pharmaceutical, biotechnology, or healthcare sectors may be considered. Familiarity with Agile and Scrum methodologies and tools like Jira or Microsoft DevOps. PMP, Agile, or Scrum certification a plus. Strong ability to lead external-facing meetings and manage vendor interactions. Education Bachelors degree in Mechanical, Biomedical, Systems, Electrical Engineering, or related field required. Masters degree preferred.