Project Manager - MES (Medical Devices / Life Sciences)

Req ID: 375284 NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. We are currently seeking a Project Manager - MES (Medical Devices / Life Sciences) to join our team in Sans Juan, Puerto Rico (PR-PR), Puerto Rico (PR). # Job Title: Project Manager – MES (Medical Devices / Life Sciences) ## Location: Puerto Rico ## Experience: 10+ years * * * ## About the Role We are seeking an experienced Project Manager (PM) to lead the implementation and delivery of Manufacturing Execution Systems (MES) within a highly regulated medical devices/life sciences environment. This 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 #LI-NorthAmerica About NTT DATA NTT DATA is a $30 billion business and technology services leader, serving 75% of the Fortune Global 100. We are committed to accelerating client success and positively impacting society through responsible innovation. We are one of the world's leading AI and digital infrastructure providers, with unmatched capabilities in enterprise-scale AI, cloud, security, connectivity, data centers and application services. our consulting and Industry solutions help organizations and society move confidently and sustainably into the digital future. As a Global Top Employer, we have experts in more than 50 countries. We also offer clients access to a robust ecosystem of innovation centers as well as established and start-up partners. NTT DATA is a part of NTT Group, which invests over $3 billion each year in R&D. Whenever possible, we hire locally to NTT DATA offices or client sites. This ensures we can provide timely and effective support tailored to each client’s needs. While many positions offer remote or hybrid work options, these arrangements are subject to change based on client requirements. 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