Title: Project Manager - MES (Medical Devices / Life Sciences)
Location: Pittsburgh, PA (Remote)
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
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- 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
- Initiatives in manufacturingKnowledge of cybersecurity frameworks in regulated environments
Regards
Krishna
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