Req ID: 375285
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: USAExperience: 10+ yearsAbout the RoleWe 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 ResponsibilitiesProject 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 QualificationsTechnical 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
