Project Manager - MES (Medical Devices / Life Sciences)

Role: Project Manager - MES (Medical Devices / Life Sciences)

Location: Pittsburgh, PA (Remote)

Type: Contract

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 CoreSQL ServerWPF 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 SciencesMedical 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 11GAMP standardsISO 13485FDA Design Controls
• Validation Expertise
• Hands-on experience with Computer System Validation (CSV)Strong documentation and audit readiness experience
• Key Skills
• Strong leadership and stakeholder managementExcellent communication and reporting skillsRisk assessment and mitigation expertiseAnalytical and problem-solving mindsetAbility to manage complex, regulated projects
• Preferred Qualifications
• Experience with eDHR implementationsExposure to digital transformation initiatives in manufacturingKnowledge of cybersecurity frameworks in regulated environments