60 Penumbra Project Manager Jobs Hiring Near You

Job Summary:
Penumbra, Inc. is a global healthcare company focused on innovative therapies. The IT Program Manager – Manufacturing and Quality Applications is responsible for leading complex, cross-functional technology programs focused on Manufacturing, Quality, and Supply Chain systems, partnering closely with various stakeholders to drive strategic initiatives.
Responsibilities:
• Own and manage the full lifecycle of complex, high-impact programs focused on Manufacturing, Quality, and Supply Chain applications, with integration into ERP and GTM systems.
• Partner with Manufacturing, Quality, and Operations leaders to define program objectives, scope, and success criteria aligned to plant and enterprise goals.
• Develop and maintain the Manufacturing IT strategic roadmap, ensuring alignment with production scalability, quality compliance, and operational efficiency.
• Drive global manufacturing process standardization, digitization, and system optimization across plants and regions.
• Lead program portfolio management for manufacturing initiatives, including prioritization, capacity planning, and dependency management across sites.
• Lead end-to-end delivery of manufacturing system implementations and enhancements (e.g., MES, QMS, shop floor systems, traceability, and production planning tools).
• Oversee integration of manufacturing systems with ERP, warehouse management, and downstream GTM platforms.
• Define and execute program governance, including communication plans, stakeholder engagement, and executive reporting with a strong focus on operational impact.
• Monitor program performance using KPIs tied to production efficiency, quality, compliance, and throughput.
• Identify, assess, and mitigate risks, particularly those impacting production continuity, regulatory compliance, and plant operations.
• Collaborate with cross-functional teams (Manufacturing, Quality, Supply Chain, IT) to define scope, timelines, and resource requirements.
• Ensure solutions are delivered on time, within budget, and meet plant operational and quality expectations.
• Lead validation and testing strategies, including integration testing, UAT, and manufacturing system validation in regulated environments.
• Drive change management across plant users, including training, communication, and adoption of new manufacturing processes and systems.
• Facilitate strong collaboration between IT and plant operations teams to ensure alignment and minimal disruption to production.
• Maintain comprehensive program documentation, including validation artifacts, risks, and compliance records.
• Conduct post-implementation reviews focused on operational improvements, production metrics, and continuous improvement.
• Ensure adherence to PMO standards, quality frameworks, and regulatory requirements (e.g., QMS, GxP where applicable).
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
• Understand relevant security, privacy, and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company.
• Ensure other members of the department follow the QMS, regulations, standards, and procedures.
• Perform other work-related duties as assigned
Qualifications:
Required:
• Bachelor's degree with 10+ years of experience in program and project management, or equivalent combination of education and experience
• Solid experience in program and project management in manufacturing, medical devices, or life science environments
• Proven experience leading large-scale programs in Manufacturing and Quality systems (e.g., MES, QMS, production planning, shop floor automation), with ERP integration
• Strong understanding of Plan-to-Produce, Quality Management, Inventory Management, and Supply Chain processes
• Experience working in regulated manufacturing environments, including system validation and compliance (QMS, FDA, ISO)
• Hands-on experience with manufacturing system implementations, plant rollouts, and multi-site deployments
• Experience managing testing strategies, including validation, integration testing, UAT, and cutover planning with hypercare support
Preferred:
• PMP, Agile, or Scrum certifications preferred
• Medical device, pharmaceutical, biotech, or other regulated industry experience desired
Company:
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Founded in 2004, the company is headquartered in Alameda, USA, with a team of 1001-5000 employees. The company is currently Late Stage.