Project Manager - MES (Medical Devices / Life Sciences)

Req ID:375285NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now.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 & ExecutionDefine 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 ManagementForecast project requirements and manage budgets effectively.Track project expenses and identify/mitigate variances proactively.Optimize resource utilization across teams and project phases.Team Leadership & DeliveryLead 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 & ComplianceIdentify 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 CommunicationAct 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 CloseoutEnsure project deliverables meet quality, regulatory, and organizational standards.Oversee post-implementation validation and documentation.Conduct post-project reviews to identify continuous improvement opportunities.Compliance & ValidationLead 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 IntegrationOversee 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 ImplementationLead 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 Expertise10+ 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 ExperienceProven experience managing MES implementations in:Life SciencesMedical Devices (Class II/III preferred)CertificationsPMP (Project Management Professional) OR Certified Scrum Master (CSM)Strong understanding of Quality Management Systems (QMS)Regulatory KnowledgeFamiliarity with:FDA 21 CFR Part 11GAMP standardsISO 13485FDA Design ControlsValidation ExpertiseHands-on experience with Computer System Validation (CSV)Strong documentation and audit readiness experienceKey SkillsStrong leadership and stakeholder managementExcellent communication and reporting skillsRisk assessment and mitigation expertiseAnalytical and problem-solving mindsetAbility to manage complex, regulated projectsPreferred QualificationsExperience with eDHR implementationsExposure to digital transformation initiatives in manufacturingKnowledge of cybersecurity frameworks in regulated environmentsAbout NTT DATANTT DATA is a $30 billion business and technology services leader, serving 75% of the Fortune Global 100. We are committed to accelerating client success and positively impacting society through responsible innovation. We are one of the world's leading AI and digital infrastructure providers, with unmatched capabilities in enterprise-scale AI, cloud, security, connectivity, data centers and application services. our consulting and Industry solutions help organizations and society move confidently and sustainably into the digital future. As a Global Top Employer, we have experts in more than 50 countries. We also offer clients access to a robust ecosystem of innovation centers as well as established and start-up partners. NTT DATA is a part of NTT Group, which invests over $3 billion each year in R&D.Whenever possible, we hire locally to NTT DATA offices or client sites. This ensures we can provide timely and effective support tailored to each client’s needs. While many positions offer remote or hybrid work options, these arrangements are subject to change based on client requirements. For employees near an NTT DATA office or client site, in-office attendance may be required for meetings or events, depending on business needs. At NTT DATA, we are committed to staying flexible and meeting the evolving needs of both our clients and employees. NTT DATA recruiters will never ask for payment or banking information and will only use @nttdata.com and @talent.nttdataservices.com email addresses. If you are requested to provide payment or disclose banking information, please submit a contact us form, .NTT DATA endeavors to make accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact us at . This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. NTT DATA is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. For our EEO Policy Statement, please click here. If you'd like more information on your EEO rights under the law, please click here. For Pay Transparency information, please click here.Posting Date:06/18/2026Department:Project Management- HP, Prov & LS - 1051710011