Program Manager: Med Devices Mfg. Experience

Role OverviewThe Project Manager – Installation & Validation will lead and oversee the end-to-end execution of installation and validation projects, ensuring timely, high-quality delivery in full compliance with GMP/GDP standards, validation requirements, and internal Quality Management System (QMS) procedures.This role drives cross-functional collaboration across Engineering, Quality, Operations, Supply Chain, IT, and external vendors to achieve all project objectives related to installation, qualification, and readiness for production.Key ResponsibilitiesProgram Leadership & GovernanceDefine and maintain the integrated program plan, scope, milestones, and budget in alignment with the Statement of Work (SOW).Establish and manage governance routines (e.g., steering committees, project reviews, risk and issue management, and change control).Maintain clear RACI matrices and ensure alignment with local site and global stakeholders.Planning, Scheduling & Resource ManagementDevelop and monitor detailed project schedules and deliverables.Allocate and manage engineering and technician resources; track utilization and adjust as needed.Ensure onboarding, training, and readiness plans for each phase are executed on schedule.Validation Lifecycle ManagementOversee IQ/OQ/TMV validation activities for equipment, lines, and production fixtures.Ensure the creation, execution, and approval of all validation protocols, test reports, and documentation (including PQ when applicable).Track validation progress, maintain traceability, and coordinate smooth handover to Manufacturing Operations.Documentation, Change Control & Data ManagementCoordinate documentation review and release in cPDM/Windchill or equivalent systems.Manage protocol and report approvals, revisions, and archival according to QMS standards.Ensure calibration, maintenance, and identification matrices are current and linked to execution timelines.Site Execution & Manufacturing ReadinessLead on-site installation, equipment layout/configuration, and commissioning activities.Coordinate with suppliers for timely repairs, replacements, and tooling readiness.Partner with Manufacturing Operations to ensure seamless transition to production.Quality, Compliance & Risk ManagementGuarantee compliance with GMP, GDP, EHS, and company policies.Identify risks, develop mitigation strategies, and escalate issues as appropriate.Support and lead internal and external audits as required.Supplier & Stakeholder ManagementManage relationships with equipment suppliers, contractors, and service providers.Maintain proactive communication with regional and global stakeholders, including site leadership and project administrators.Training & Knowledge TransferFacilitate knowledge transfer to on-site engineers and operators through job aids, SOP updates, and training sessions.Document and track all training activities.Reporting & InsightsDeliver regular project status updates, dashboards, and risk reports to leadership.Lead post-project reviews and lessons-learned sessions to drive continuous improvement.Qualifications & ExperienceBachelor’s degree in Engineering or related technical field.Master’s degree (MBA or equivalent) is a plus.5+ years in program or project management within medical device or high-tech manufacturing environments.Proven experience leading cross-functional and multi-site project teams.Technical Skills:In-depth understanding of Validation (IQ/OQ/PQ/TMV) and manufacturing processes.Familiarity with DOE, GD&T, statistical analysis tools (e.g., Minitab), and data analytics.Knowledge of GMP/GDP and related regulatory frameworks.Experience with document control systems and Product Lifecycle Management (PLM) tools (e.g., Windchill, cPDM).Ability to interpret engineering drawings and technical specifications.Leadership & Communication:Strong stakeholder management, negotiation, and communication skills (English and Spanish).Proven ability to coach, influence, and motivate diverse teams.Certifications:PMP or equivalent certification preferred.Six Sigma Green/Black Belt certification is a plus.Other Requirements:Willingness to travel (domestically and internationally) as required.Ability to work in cleanroom environments following gowning and safety protocols.Language Requirements:Fluency in English and Spanish (spoken and written).Ability to operate effectively in a multinational, matrixed organization.