Project Manager - MES (Medical Devices / Life Sciences)

NTT DATA Services•West Mifflin, PA

4d•Onsite

About The Position

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.

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 and 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 Haves

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

Responsibilities

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.