Senior PLM Windchill Solution Architect - Remote with Travel

Job Description

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