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
| Location | Warsaw, 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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