Project Manager - MES (Medical Devices / Life Sciences)

Project Manager – MES (Medical Devices / Life Sciences) Req ID: 375284 Location: Puerto Rico Experience: 10+ years About the Role We are currently seeking a Project Manager – MES (Medical Devices / Life Sciences) to join our team in Sans Juan, Puerto Rico. The role requires strong technical expertise, regulatory knowledge, and leadership capabilities to manage cross‑functional teams and ensure compliance with FDA and industry standards. Key Responsibilities Project Planning & Execution Define project scope, objectives, and deliverables in collaboration with senior management and key stakeholders. Develop comprehensive project plans including timelines, milestones, and resource allocation. Drive end‑to‑end execution of MES implementation projects, ensuring alignment with organizational goals. Budget & Resource Management Forecast project requirements and manage budgets effectively. Track project expenses and identify/mitigate variances proactively. Optimize resource utilization across teams and project phases. Team Leadership & Delivery Lead cross‑functional teams including software engineers, automation specialists, and QA teams. Delegate tasks effectively, ensuring accountability and high performance. Drive delivery using Agile or hybrid SDLC methodologies. Risk Management & Compliance Identify and mitigate project risks, issues, and bottlenecks. Ensure adherence to cybersecurity, data integrity, and validation requirements. Maintain audit trails and ensure compliance with Device History Records (DHR) requirements. Stakeholder Communication Act as the primary point of contact for stakeholders. Provide regular status updates, performance metrics, and executive reports. Facilitate communication between business, IT, and manufacturing teams. Quality Assurance & Project Closeout Ensure project deliverables meet quality, regulatory, and organizational standards. Oversee post‑implementation validation and documentation. Conduct post‑project reviews to identify continuous improvement opportunities. Compliance & Validation Lead Computer System Validation (CSV) processes ensuring all MES applications meet regulatory standards. Ensure compliance with FDA 21 CFR Part 11 and GAMP guidelines . Manage validation documentation including IQ/OQ/PQ protocols. Shop Floor Integration Oversee integration of .NET‑based MES systems with plant floor systems (PLCs, SCADA). Enable connectivity between manufacturing operations and enterprise systems (ERP). Ensure traceability for production metrics and genealogy tracking. eDHR Implementation Lead transition from paper‑based systems to Electronic Device History Records (eDHR) . Collaborate closely with IT, Quality, and Manufacturing teams to ensure seamless adoption. Required Qualifications Technical Expertise 10+ years of strong proficiency in: C#, ASP.NET, .NET Core SQL Server WPF or Blazor (for HMI/Dashboard development) 5+ years of experience with MES architecture and shop floor system integration (PLCs, SCADA). Domain Experience Proven experience managing MES implementations in: Life Sciences Medical Devices (Class II/III preferred) Certifications PMP (Project Management Professional) OR Certified Scrum Master (CSM) Strong understanding of Quality Management Systems (QMS) Regulatory Knowledge Familiarity with: FDA 21 CFR Part 11 GAMP standards

ISO 13485

FDA Design Controls Validation Expertise Hands‑on experience with Computer System Validation (CSV) Strong documentation and audit readiness experience Key Skills Strong leadership and stakeholder management Excellent communication and reporting skills Risk assessment and mitigation expertise Analytical and problem‑solving mindset Ability to manage complex, regulated projects Preferred Qualifications Experience with eDHR implementations Exposure to digital transformation initiatives in manufacturing Knowledge of cybersecurity frameworks in regulated environments NTT DATA is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. For our EEO Policy Statement, please click here ( If you'd like more information on your EEO rights under the law, please click here ( For Pay Transparency information, please click here ( #J-18808-Ljbffr NTT America, Inc.