PMO Manager
My Client is seeking a highly skilled and technically proficient PMO Manager to lead our Program Management Office within a fast-paced, regulated medical device contract manufacturing environment. This role requires a strong engineering background, hands-on experience in product development and manufacturing, and the ability to drive cross-functional teams toward successful project execution.
Key Responsibilities:
- Lead and manage the PMO team, ensuring alignment with company goals and customer expectations.
- Oversee end-to-end program execution for multiple concurrent medical device projects, from concept through commercialization.
- Develop and maintain project plans, schedules, budgets, and resource allocations using industry-standard tools.
- Collaborate closely with engineering, quality, regulatory, operations, and supply chain teams to ensure technical feasibility and manufacturability.
- Implement and refine project management methodologies, tools, and templates tailored to the medical device industry.
- Drive risk management, issue resolution, and change control processes across all programs.
- Ensure compliance with FDA, ISO 13485, and other relevant regulatory standards.
- Provide technical leadership and guidance during design reviews, process validations, and customer audits.
- Serve as a key liaison between internal teams and external clients, ensuring clear communication and stakeholder alignment.
- Monitor and report on KPIs, program health, and resource utilization to senior leadership.
Qualifications:
- Bachelor's or Master's degree in Engineering (Mechanical, Biomedical, Electrical, or related field); PMP certification preferred.
- 8+ years of experience in medical device manufacturing, with at least 3 years in a PMO or program management leadership role.
- Proven track record of managing complex, cross-functional projects in a regulated environment.
- Strong understanding of design controls, validation, and regulatory compliance.
- Hands-on experience with manufacturing processes, including injection molding, assembly, automation, and testing.
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