Req ID: 375285 

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 Pittsburgh, Pennsylvania (US-PA), United States (US).

Job Title: Project Manager – MES (Medical Devices / Life Sciences)

Location: USA

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