Project Manager - MES (Medical Devices / Life Sciences) - Sans Juan, PR (Remote)

[Sid K]

Hi  Folks,

My client is looking for Project Manager - MES (Medical Devices / Life Sciences) for 5 Month Contract role based in Sans Juan, PR (Remote)

 

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

Location: Sans Juan, PR (Remote)

Duration: 5 Month 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 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 11GAMP standards ISO 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 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

Thanks

Sid