Role OverviewThe Senior Architect will be responsible for ensuring architecture and delivery practices align with regulated Med Device expectations, including FDA QMSR, ISO 13485, GxP, CSV, 21 CFR Part 11, UDI, GUDID, EU MDR/EUDAMED, audit readiness, and traceability expectations. They will also partner with Quality and Regulatory stakeholders to ensure Windchill changes, enhancements, migration activities, integrations, and automation use cases follow appropriate validation controls.
What You Will Do
The Senior Architect will identify and lead automation opportunities across repetitive incidents, access requests, change management scenarios, publishing issues, integration failures, health checks, data corrections, reporting, and knowledge base responses. They will also drive adoption of AI-assisted search, ticket summarization, knowledge mining, root cause recommendation, automated support diagnostics, and support productivity tools.
Why It Might Be a Fit
The Senior Architect will measure benefits from automation, such as ticket reduction, faster resolution, improved data quality, reduced manual effort, SLA improvement, and user productivity gains. They will also support pre-sales, RFP responses, renewal proposals, solution presentations, estimation, and account planning.
Requirements
- 10+ years of experience in architecture and delivery practices
- Strong understanding of regulated Med Device expectations, including FDA QMSR, ISO 13485, GxP, CSV, 21 CFR Part 11, UDI, GUDID, EU MDR/EUDAMED, audit readiness, and traceability expectations
- Ability to partner with Quality and Regulatory stakeholders to ensure Windchill changes, enhancements, migration activities, integrations, and automation use cases follow appropriate validation controls
- Experience with AI-assisted search, ticket summarization, knowledge mining, root cause recommendation, automated support diagnostics, and support productivity tools
Benefits
- Competitive salary
- Equity in the company
- Opportunities for growth and professional development
- Collaborative and dynamic work environment
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