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IT Jobs in Warsaw, IN

Senior PLM Windchill Solution Architect - Remote with Travel

The Dignify Solutions, LLC
  • Warsaw, IN
  • Remote
  • Instant Apply
30+ days ago

Job Description

Required Experience
  • 10+ years of hands-on PTC Windchill experience.
  • Demonstrated experience in the Medical Device domain, which is a key requirement for this role.
  • UDI (Unique Device Identification) knowledge should be evident in the profile.
  • Experience with FDA QMSR / 21 CFR Part 11 compliance and regulatory requirements.
  • Candidate should have exposure to OR certification relation experience on/with ISO 13485.
  • Experience with Validation Documentation activities, including IQ/OQ/PQ, should be evident.
  • Candidate should have visible experience for Production support, issue management, environment support
  • Candidate should have experience on AI / Automation Leadership and Regulatory Systems Integration
  • 5+ years as Solution Architect, Technical Architect, Lead Architect, or equivalent role.
  • Experience leading customer-facing architecture discussions for US or global customers.
  • Experience with AMS, enhancement, implementation, integration, migration, upgrade, validation, and support tracks.
  • Experience managing offshore or distributed delivery teams.
  • Prior Medical Device, Life Sciences, Manufacturing, Automotive, Aerospace, or regulated industry experience is strongly preferred.
  • Experience in proposal support, CR estimation, scope management, and customer stakeholder management is mandatory for this role.
Preferred
  • PTC Windchill certification.
  • AWS or Azure certification.
  • ITIL certification.
  • ISO 13485, CSV, GxP, or Med Device validation training.
  • AI/GenAI, Microsoft Copilot, Azure AI, or prompt engineering certification

Numbers & Facts

LocationWarsaw, IN (
Remote
)

Skills

  • Aerospace and Defenseunmatched
  • Amazon Web Services (AWS)unmatched
  • Artificial Intelligence (AI)unmatched
  • Automationunmatched
  • Automotive Manufacturingunmatched
  • Biologyunmatched
  • Code of Federal Regulationsunmatched
  • Customer Relationsunmatched
  • FDA (Food and Drug Administration)unmatched
  • GxPunmatched
  • ISO (International Organization for Standardization)unmatched
  • ITIL (IT Infrastructure Library)unmatched
  • Leadershipunmatched
  • Medical Equipmentunmatched
  • Microsoft Windows Azureunmatched
  • Process Validationunmatched
  • Product Lifecycle Managementunmatched
  • Production Supportunmatched
  • Regulationsunmatched
  • Regulatory Complianceunmatched
  • Regulatory Requirementsunmatched
  • System Integration (SI)unmatched
  • Validation Documentationunmatched
  • Windchill PLM Softwareunmatched

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