Test Architect
Core
Architecting end-to-end automated testing, post-deployment verification, and tool validation for regulated AI-driven medical device software (SaMD) products.
Role type
Senior individual contributor technical leader (Test Architect)
Builds
End-to-end testing frameworks, AI-assisted automation pipelines, and validation evidence for medical imaging and clinical data systems.
Domain
Medical technology / Software as a Medical Device (SaMD) / AI-driven diagnostics
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Test strategy for regulated SaMD, Medical device QMS (ISO 13485, IEC 62304, ISO 14971, 21 CFR Part 820), Selenium/Playwright framework architecture, API/contract testing, CI/CD integration, distributed system debugging, AI-assisted testing adoption, requirements traceability
Preferred skills
DICOM/HL7 protocols, RA/QA audit leadership, ML/AI test strategy, complex visualization validation, legacy desktop automation, performance testing (k6, Locust, JMeter, Gatling)
Technologies
Selenium, Playwright, REST Assured, Postman, Karate, Pact, AWS, Python, TypeScript/JavaScript, Java, C#
Responsibilities
Set technical strategy for E2E test automation and AI-first testing approaches; Architect post-deployment testing and tool validation; Define test depth based on safety classification; Author complex test plans and protocols; Lead tool validation for regulatory compliance; Mentor engineers and define hiring profiles; Influence cross-functional quality decisions.
Seniority
Senior, hands-on IC with leadership scope