NTT

1 month ago

Project Manager - MES (Medical Devices / Life Sciences)

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Last checked: 12 hours agoStatus: Live

Job Summary

Lead end-to-end implementation and delivery of Manufacturing Execution Systems (MES) in a highly regulated medical devices/life sciences environment. Own project planning, budgets, and risk management while coordinating cross-functional teams spanning software, automation, QA, IT, Quality, and Manufacturing. Drive Agile/hybrid delivery, ensure compliance with FDA 21 CFR Part 11, GAMP, ISO 13485, and manage CSV, IQ/OQ/PQ documentation, and eDHR transitions including plant-floor integrations.

Location: Puerto Rico

Workplace: Onsite

Employment Type: Full time

Job Function: Program & Project Management (PMO)

Seniority: Manager level

Key Responsibilities

•Define project scope, objectives, and deliverables with senior management and stakeholders.
•Develop and manage project plans, timelines, milestones, and resource allocation for MES delivery.
•Lead cross-functional teams (software engineers, automation specialists, QA) and delegate tasks to ensure high performance.
•Manage budgets and proactively track/mitigate project risks, issues, and bottlenecks while ensuring compliance and data integrity.
•Oversee integration of .NET-based MES with plant-floor systems (PLCs, SCADA), drive validation/CSV and IQ/OQ/PQ documentation, and ensure eDHR transition and documentation readiness.

Key Requirements

•10+ years of proficiency implementing MES in regulated environments, including expertise with C#, ASP.NET, .NET Core, and SQL Server.
•5+ years of experience with MES architecture and shop-floor system integration (PLCs, SCADA).
•Hands-on Computer System Validation (CSV) experience and strong documentation/audit readiness.
•Experience managing MES implementations in life sciences and medical devices (Class II/III preferred).
•PMP (or Certified Scrum Master/CSM) plus understanding of Quality Management Systems (QMS) and familiarity with FDA 21 CFR Part 11, GAMP, ISO 13485, and FDA Design Controls.

Experience:10+ yearsLife sciencesMedical devicesRegulated environments

Skills:LeadershipStakeholder managementCommunicationRisk assessmentAnalytical problem-solving

Certifications:PMPCertified Scrum Master (CSM)

Tech Stack:C#ASP.NETNET Core.NET CoreSQL ServerWPFBlazorMESPLCsSCADAERPAgileHybrid SDLCCSVIQOQPQEDHRDHRDevice History Records

Company Brief

NTT

Dimension Data, operating under NTT Ltd, provides managed IT services, cloud and data center solutions, networking, cybersecurity, and digital transformation services to enterprise customers worldwide.

Industry: Professional Services

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Established Company

Valuation: Public Company (Market Cap in USD)

Headquarters: London, United Kingdom

Founded: 1983

Website LinkedIn

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NTT