NTT

1 month ago

Project Manager - MES (Medical Devices / Life Sciences)

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Last checked: 4 hours agoStatus: Live

Job Summary

Lead end-to-end implementation and delivery of Manufacturing Execution Systems (MES) in a regulated medical devices/life sciences environment. Own project planning, budgeting, risk and compliance (including FDA requirements), and stakeholder communication across business, IT, QA, and manufacturing. Drive Agile/hybrid delivery, manage shop-floor integration with PLC/SCADA and ERP connectivity, and oversee validation activities such as CSV and IQ/OQ/PQ documentation.

Location: Pittsburgh

Workplace: Onsite

Employment Type: Full time

Job Function: Program & Project Management (PMO)

Seniority: Manager level

Key Responsibilities

•Define project scope, objectives, deliverables, and comprehensive plans (timelines, milestones, resource allocation) with senior stakeholders.
•Drive end-to-end MES implementation execution, aligning delivery with organizational goals.
•Forecast and manage budgets, track expenses, and proactively identify/mitigate variances.
•Lead cross-functional teams (software engineers, automation specialists, QA), delegate tasks, and ensure accountability using Agile/hybrid SDLC methodologies.
•Ensure regulatory and validation compliance (FDA 21 CFR Part 11, GAMP, DHR/eDHR, cybersecurity, data integrity) and oversee post-implementation validation, documentation, and closeout.

Key Requirements

•10+ years proficiency with C#, ASP.NET, .NET Core, SQL Server, and WPF or Blazor for HMI/dashboard development.
•5+ years experience with MES architecture and shop-floor system integration (PLCs, SCADA).
•Experience managing MES implementations in life sciences, with medical devices (Class II/III) preferred.
•PMP (or) Certified Scrum Master (CSM), plus strong understanding of Quality Management Systems (QMS).
•Hands-on Computer System Validation (CSV) experience and strong documentation/audit readiness.

Experience:10+ yearsLife sciencesMedical devicesMESRegulated environmentsMedicalMedical device manufacturing

Skills:LeadershipStakeholder managementCommunicationRisk assessmentProblem-solving

Certifications:PMPCertified Scrum Master (CSM)

Tech Stack:C#ASP.NETNET Core.NET CoreSQL ServerWPFBlazor.NETPLCsSCADAERPAgileSDLCIQ/OQ/PQCSVDHREDHR

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