Test Architect
Core
Senior technical leader architecting end-to-end automated testing, post-deployment verification, and tool validation for regulated AI-driven medical device software (SaMD).
Role type
Senior IC Test Architect (Regulated SaMD)
Builds
End-to-end testing frameworks, AI-assisted automation pipelines, and validation evidence for medical imaging and clinical data systems.
Domain
Healthcare / Medical Devices / AI & Machine Learning
Deliverable
production ML models
Required skills
Test strategy for regulated SaMD, Medical device QMS (ISO 13485, IEC 62304, ISO 14971, 21 CFR Part 820), Selenium/Playwright framework architecture, AI-assisted test automation, API/contract testing, CI/CD integration, Distributed systems debugging, Requirements traceability
Preferred skills
DICOM/HL7 protocols, Requirements tooling (Ketryx, Jama, Polarion), ML/AI test strategy, 3D visualization validation, Legacy desktop automation (WinAppDriver), Performance testing (k6, Locust, JMeter)
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 approaches; Architect post-deployment testing and tool validation; Author complex test plans and protocols for regulated environments; Lead root-cause investigations and quality audits; Mentor engineers and define hiring profiles.
Seniority
Senior, hands-on IC
