Sr Architect (US - NJ - BIRLASOFT OFFICE, US)

Birlasoft
New Jersey
Workplace: OnsiteFull timeFunction: Solutions Engineering & Sales EngineeringSkills: ["Stakeholder management","Risk assessment","Audit readiness","Continuous improvement","Automation enablement"]

Lead medical-device domain architecture and delivery for regulated PLM/AMS initiatives, ensuring practices align with FDA/ISO/GxP requirements and audit readiness. Partner with Quality and Regulatory to guide validation documentation, traceability, and safe change controls for Windchill enhancements, migrations, integrations, and automation use cases. Identify automation and AI-assisted support opportunities to improve SLAs and data quality, while supporting growth via AMS insights, RFP/pre-sales activities, and renewal planning.

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FursaFursa
Birlasoft
Birlasoft
3 hours ago

Sr Architect (US - NJ - BIRLASOFT OFFICE, US)

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Last checked: 3 hours agoStatus: Live

Job Summary

Lead medical-device domain architecture and delivery for regulated PLM/AMS initiatives, ensuring practices align with FDA/ISO/GxP requirements and audit readiness. Partner with Quality and Regulatory to guide validation documentation, traceability, and safe change controls for Windchill enhancements, migrations, integrations, and automation use cases. Identify automation and AI-assisted support opportunities to improve SLAs and data quality, while supporting growth via AMS insights, RFP/pre-sales activities, and renewal planning.
Location: New Jersey
Workplace: Onsite
Employment Type: Full time
Job Function: Solutions Engineering & Sales Engineering
Seniority: Mid level

Key Responsibilities

  • •Ensure architecture and delivery practices meet regulated medical device expectations (FDA/ISO/GxP/CSV), including audit readiness and traceability.
  • •Support validation and compliance documentation (validation plans, IQ/OQ/PQ inputs, test evidence, requirement traceability, risk/impact assessment) and partner with Quality/Regulatory.
  • •Guide Windchill change, enhancement, migration, integration, and automation initiatives with appropriate validation controls to protect patient safety, product quality, and data integrity.
  • •Identify and lead automation and AI-assisted search/ticket summarization/knowledge mining use cases aligned with security, access control, validation, audit trails, and data privacy guardrails.
  • •Drive account growth by turning recurring AMS insights and modernization needs into enhancement proposals, pre-sales/RFP responses, renewals, and solution presentations.

Key Requirements

Experience:Medical devicesPLMRegulated industry
Skills:Stakeholder managementRisk assessmentAudit readinessContinuous improvementAutomation enablement
Tech Stack:WindchillFDA QMSRISO 13485GxPCSV21 CFR Part 11UDIGUDIDEU MDREUDAMEDDHFDMRIQ/OQ/PQValidation documentationRIMS

Company Brief

Birlasoft
Birlasoft is a global IT services and digital solutions provider delivering consulting, enterprise applications, cloud, and infrastructure services to enterprises across industries, helping accelerate digital transformation and business modernization.
Industry: Professional Services
Company Size: Enterprise (1,001+ employees)
Revenue: USD 500M to 1B
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Noida, India
WebsiteLinkedIn