Sr Architect

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• Ensure 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.
• Support validation documentation such as validation plans, IQ/OQ/PQ inputs, test evidence, requirement traceability, risk assessment, impact assessment, and validation summary support.
• Partner with Quality and Regulatory stakeholders to ensure Windchill changes, enhancements, migration activities, integrations, and automation use cases follow appropriate validation controls.
• Understand Med Device business processes such as DHF, DMR, change control, product documentation, regulatory submissions, UDI, RIMS, quality records, manufacturing data, supplier quality, and post-market traceability.
• Ensure changes do not compromise patient safety, product quality, data integrity, or audit readiness.

• 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.
• Drive adoption of AI-assisted search, ticket summarization, knowledge mining, root cause recommendation, automated support diagnostics, and support productivity tools.
• Define AI use cases in alignment with enterprise security, access control, validation, audit trail, data privacy, and responsible AI guardrails.
• Measure benefits from automation, such as ticket reduction, faster resolution, improved data quality, reduced manual effort, SLA improvement, and user productivity gains.

• Proactively identify growth opportunities from AMS insights, recurring pain points, automation potential, modernization needs, integration gaps, regulatory needs, upgrade needs, and user adoption challenges.
• Convert recurring issues into enhancement proposals, automation initiatives, optimization projects, technical debt reduction proposals, and roadmap items.
• Support pre-sales, RFP responses, renewal proposals, solution presentations, estimation, and account planning.
• Partner with customer and internal leadership to position Birlasoft as a strategic PLM partner, not only as an AMS provider.
• Drive measurable value in stability, cost optimization, operational efficiency, risk reduction, regulatory readiness, and innovation.