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NTT DATA Logo NTT DATA · IT - Software Development

Project Manager - MES (Medical Devices / Life Sciences)

Puerto Rico, San Juan Employment contract · Job Posted June 16, 2026
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Job Description

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). 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.

Job Responsibility

  • 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
  • Forecast project requirements and manage budgets effectively
  • Track project expenses and identify/mitigate variances proactively
  • Optimize resource utilization across teams and project phases
  • 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
  • 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
  • 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
  • Ensure project deliverables meet quality, regulatory, and organizational standards
  • Oversee post-implementation validation and documentation
  • Conduct post-project reviews to identify continuous improvement opportunities
  • 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
  • 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
  • Lead transition from paper-based systems to Electronic Device History Records (eDHR)
  • Collaborate closely with IT, Quality, and Manufacturing teams to ensure seamless adoption

Requirements

  • 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)
  • Proven experience managing MES implementations in: Life Sciences, Medical Devices (Class II/III preferred)
  • PMP (Project Management Professional) OR Certified Scrum Master (CSM)
  • Strong understanding of Quality Management Systems (QMS)
  • Familiarity with: FDA 21 CFR Part 11, GAMP standards, ISO 13485, FDA Design Controls
  • Hands-on experience with Computer System Validation (CSV)
  • Strong documentation and audit readiness experience
  • 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

Nice to have

  • Experience with eDHR implementations
  • Exposure to digital transformation initiatives in manufacturing
  • Knowledge of cybersecurity frameworks in regulated environments
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