Prior Medical Device, Life Sciences, Manufacturing, Automotive, Aerospace, or regulated industry experience is strongly preferred. Experience leading customer-facing architecture discussions for US or global customers.
Numbers & Facts
Location
Warsaw, IN (Remote)
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