Sr Architect

Birlasoft Limited

About The Position

This role focuses on providing architectural leadership in validation, compliance, and the medical device domain, as well as driving AI, automation, and continuous improvement initiatives. The Sr Architect will also play a key role in identifying and supporting revenue growth and account expansion opportunities. A strong understanding of medical device regulations and business processes is essential, as is the ability to leverage AI and automation to enhance service delivery and identify new business opportunities.

Requirements

Strong understanding of medical device regulations (FDA QMSR, ISO 13485, GxP, CSV, 21 CFR Part 11, UDI, GUDID, EU MDR/EUDAMED).
Experience with validation documentation (validation plans, IQ/OQ/PQ, test evidence, traceability, risk assessment, impact assessment).
Knowledge of Med Device business processes (DHF, DMR, change control, product documentation, regulatory submissions, UDI, RIMS, quality records, manufacturing data, supplier quality, post-market traceability).
Experience in identifying and implementing automation opportunities.
Familiarity with AI use cases in a business context.
Experience in supporting pre-sales activities, RFP responses, and account planning.
Ability to position a company as a strategic partner.

Nice To Haves

Experience with Windchill.
Experience with AI-assisted search, ticket summarization, knowledge mining, root cause recommendation, automated support diagnostics, and support productivity tools.
Understanding of enterprise security, access control, validation, audit trail, data privacy, and responsible AI guardrails.

Responsibilities

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.