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Exposure Management Architect

Openkyber

Senior Windchill Architect (Medical Device Industry) AMS Client-Facing Role 10+ Years of Experience. Preferred location Warsaw, IN. We are looking for a Senior Solution Architect, PTC Windchill PLM to lead a strategic, customer- facing engagement for a US-based Medical Device customer. The Architect will own end-to-end solution architecture, technical governance, AMS leadership, enhancement roadmap, integration strategy, migration oversight, validation alignment, and stakeholder engagement across a complex Windchill and ThingWorx ecosystem. This role requires a senior techno-functional leader who can work closely with customer IT, Engineering, Quality, Regulatory, Manufacturing, Support, and business stakeholders while also guiding offshore teams across Windchill development, integrations, migration, validation, AMS support, deployment, and continuous improvement tracks. The role is not limited to technical architecture. The Architect must also drive customer confidence, scope control, CR shaping, estimation, delivery governance, risk management, automation adoption, operational efficiency, and account growth. The engagement also includes complex integrations such as MDM, UDI, iLearn, OpenText, Website, GTS, Vault, and regulatory process flows. The Architect will be expected to convert AMS from a support-led model into a value-led operating model by reducing recurring incidents, identifying automation opportunities, improving SLA performance, enabling AI-driven diagnostics, supporting renewals, expanding scope, and generating additional revenue opportunities A. Customer-Facing Architecture Leadership Act as the senior customer-facing PTC Windchill Solution Architect and trusted advisor for the customer s PLM ecosystem. Lead architecture discussions with customer IT, Engineering, Quality, Regulatory Affairs, Manufacturing, and business process owners. Own architecture governance for Windchill PDMLink, ThingWorx/Navigate, Change Management, Document Management, BOM Management, CAD integration, data load, integrations, migration, validation, and environment support. Explain solution options, trade-offs, technical risks, regulatory impact, effort estimates, and delivery implications to both technical and non-technical stakeholders. Lead solution walkthroughs, design reviews, estimation reviews, scope discussions, and executive-level service reviews. Build strong customer relationships to support continuity, renewal, value realization, and expansion opportunities. B. Windchill AMS and Support Governance Lead architecture oversight for Windchill AMS L1, L2 L3 support, ThingWorx support, data maintenance, deployment support, service requests, problem records, standard changes, and production incident management. Govern issue triage, root cause analysis, corrective actions, recurring incident reduction, and knowledge base improvements. Provide technical direction for incident resolution involving workflows, lifecycle states, access controls, publishing, queues, integrations, rehosts, data corrections, metadata updates, and environment issues. Review system health, SLA performance, backlog, repeated incidents, high-volume categories, and operational KPIs with customer stakeholders. Drive operational maturity across 24x5 support, offshore governance, escalation handling, and proactive risk management. C. Validation, Compliance and Medical Device Domain Leadership 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. D. AI, Automation and Continuous Improvement 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. E. Revenue Growth and Account Expansion 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 OpenKyber 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. Required Technical Skills PTC Windchill Core Strong hands-on experience in PTC Windchill PLM, preferably Windchill 11.x, 12.x, 13.x, or Windchill+ exposure. Deep knowledge of Windchill PDMLink, Change Management, Document Management, Part Management, BOM Management, Workflow, Lifecycle, Type and Attribute Management, Access Controls, Teams, Preferences, and Business Administration. Experience with ThingWorx/Navigate, CAD integrations, publishing, WVS, visualization, and multi-environment support is strongly preferred. Understanding of Windchill architecture including MethodServer, Background MethodServer, Web Server, database, vaults, queues, file servers, clusters, load balancing, and Solr indexing. Experience supporting multi-environment landscapes such as DEV, TEST, QA, VAL, PROD, training, migration, and sandbox environments. Strong knowledge of Medical Device regulations including FDA QMSR, ISO 13485, GxP, CSV, 21 CFR Part 11, UDI, GUDID, and EU MDR/EUDAMED. Experience in AI, GenAI, Microsoft Copilot, Azure AI, or prompt engineering certification.

For applications and inquiries, contact:View email address on us.fitly.work

Vacancy posted 2 days ago
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