Project Manager - MES (Medical Devices / Life Sciences)

Project Manager – MES (Medical Devices / Life Sciences)

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.

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

• Familiarity with FDA 21 CFR Part 11, GAMP standards, ISO 13485, FDA Design Controls

Validation Expertise

• Hands-on experience with Computer System Validation (CSV)
• Strong documentation and audit readiness experience

Key Skills

• 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

Preferred Qualifications

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