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NTT DATA Logo NTT DATA · IT - Software Development

Senior Manufacturing Application Project Manager

Puerto Rico, Juncos · Job Posted July 04, 2026
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Job Description

We are seeking an experienced Project Manager with a strong background in Manufacturing Execution Systems (MES) within the Life Sciences / Medical Devices domain. The ideal candidate will lead complex, cross-functional projects involving software validation, shop floor integration, and regulatory compliance, ensuring successful delivery within scope, schedule, and budget.

Job Responsibility

  • Define project scope, objectives, and deliverables in collaboration with senior leadership and stakeholders
  • Develop and manage detailed project plans, including timelines, milestones, and resource allocation
  • Drive execution of MES-related initiatives using Agile or hybrid SDLC methodologies
  • Forecast project requirements and manage budgets effectively
  • Track expenses, analyze variances, and implement corrective actions
  • Optimize resource utilization across cross-functional teams
  • Lead and mentor diverse teams comprising software engineers, automation experts, and QA professionals
  • Delegate tasks effectively, ensuring accountability and high performance
  • Foster collaboration across IT, manufacturing, and quality functions
  • Identify and mitigate potential risks, issues, and bottlenecks proactively
  • Ensure adherence to FDA 21 CFR Part 11, GAMP, and ISO 13485 standards
  • Enforce cybersecurity, data integrity, and audit trail requirements
  • Act as the primary point of contact for project stakeholders
  • Provide regular status updates, performance metrics, and executive reports
  • Facilitate alignment between business, IT, and manufacturing teams
  • Oversee Computer System Validation (CSV) activities, ensuring all configurations are documented and validated
  • Ensure all deliverables meet quality standards and regulatory compliance
  • Conduct post-project reviews and identify improvement opportunities
  • Manage .NET-based architecture integrating shop floor systems (PLCs, SCADA) with enterprise systems (ERP)
  • Enable tracking of production metrics, genealogy, and electronic batch records
  • Support transition to Electronic Device History Records (eDHR) systems

Requirements

  • 7+ years of strong hands-on experience with: C#, ASP.NET, .NET Core
  • SQL Server
  • WPF or Blazor for dashboards / HMI development
  • 5+ years of proven experience managing MES implementations in Life Sciences or Medical Devices (Class II/III) environments
  • 5+ years of hands-on involvement in shop floor automation and integration
  • PMP (Project Management Professional) or Certified Scrum Master (CSM)
  • Strong understanding of Quality Management Systems (QMS)
  • Expertise in: FDA 21 CFR Part 11
  • GAMP (Good Automated Manufacturing Practice)
  • ISO 13485
  • FDA Design Controls
  • Mandatory experience in Computer System Validation (CSV)
  • Experience with eDHR (Electronic Device History Records) implementation
  • Ability to work in highly regulated environments with strict documentation practices
  • Bilingual communication skills (English & Spanish)
  • Ability to work onsite or coordinate with plant operations in Juncos, PR
  • Strong analytical and problem-solving capabilities

Nice to have

  • Experience with Agile / hybrid delivery models
  • Strong stakeholder management and communication skills
  • Ability to operate in fast-paced, regulated manufacturing environments
  • Familiarity with cybersecurity practices in medical manufacturing
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