AI-Driven Test Architect for Regulated SaMD

HeartFlow, Inc.; San Francisco, Northern (CA, KY); Hybrid; USD 190,000 - 250,000; Full time

Job summary

HeartFlow, Inc. is seeking a senior Test Architect to lead end-to-end automated testing across our SaMD platform.

You will define frameworks, drive AI-first testing, and align with QMS regulatory standards while partnering with RA/QA and engineering leadership. The role covers UI, API, and 3D-visualization components, with ownership of test strategy, evidence generation, and continuous improvement across CI/CD.

Qualifications

• 8–12 years of experience in software test engineering or QA leadership.
• Regulated SaMD testing experience and ownership of test strategy on shipped products.
• Deep knowledge of medical device QMS standards (ISO 13485, IEC 62304, ISO 14971, 21 CFR 820).
• Expert proficiency with Selenium/WebDriver and Playwright at scale.
• Experience designing scalable end-to-end automation frameworks.
• Ability to define test plans, protocols, and traceability across requirements.
• Experience with AI-assisted testing tools and CI/CD integration.
• Experience with API testing (REST Assured, Postman, Karate) and cloud environments (AWS).
• Excellent communication and leadership to influence cross-functional teams.

Responsibilities

• Set and evolve the technical strategy for end-to-end test automation across the full pipeline.
• Drive AI-first testing approaches and LLM-driven triage across teams.
• Architect and own post-deployment testing incl. production smoke and synthetic monitoring.
• Design test depth per component safety classification with deeper verification where needed.
• Create complex test plans, protocols, and reports under QMS standards.
• Lead tool validation strategy for test infrastructure with RA/QA alignment.
• Build and improve UI/mobile automation using Selenium and Playwright.
• Define API and integration testing standards (REST Assured, Postman, Karate, Pact).
• Partner with engineering/product/RA/QA to translate requirements into verifiable strategies.
• Own requirements management traceability tooling and audit-ready evidence.
• Lead root-cause investigations and prevent recurrence.
• Integrate automated tests into CI/CD for fast feedback.
• Support regulatory submissions with test evidence and documentation.
• Mentor engineers and lead technical reviews; help grow the team.
• Contribute to hiring and interviewing for Test Engineering roles.
• Influence quality strategy and tooling investments.

Skills

SDET / QA leadership

Automation framework design

End-to-end testing

AI-assisted testing

Test strategy ownership

Regulated SaMD testing

Education

Bachelor's degree in Computer Science or related field

Tools

Selenium/WebDriver

Playwright

REST Assured

Postman

Karate

Job description

HeartFlow, Inc. is seeking a senior Test Architect to lead end-to-end automated testing across our SaMD platform.

You will define frameworks, drive AI-first testing, and align with QMS regulatory standards while partnering with RA/QA and engineering leadership. The role covers UI, API, and 3D-visualization components, with ownership of test strategy, evidence generation, and continuous improvement across CI/CD.