Senior PLM Windchill Solution Architect - Remote with Travel
Technology
Job Description
Job DescriptionRequired 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