Lead AI-Driven SaMD Testing & Automation

HeartFlow, Inc.; San Francisco, Northern (CA, KY); Hybrid; USD 165,000 - 205,000; Full time

Job summary

HeartFlow, Inc. is recruiting a Senior Test Engineer to drive end-to-end automated testing across UI, API, and ML pipelines for our SaMD products.

The role focuses on building AI-assisted automation, validating medical device software under QMS, and scaling the test program with offshore teams and contractors. You will design and maintain E2E automation, develop golden datasets for ML validation, and ensure traceability from requirements to evidence in a regulated environment.

Qualifications

• 5–8 years of experience in software test engineering, SDET, or quality engineering roles with hands-on automation.
• Direct experience testing Software as a Medical Device (SaMD) or other regulated medical device software.
• Working knowledge of medical device QMS practices and standards (ISO 13485, IEC 62304, ISO 14971, 21 CFR Part 820).
• Strong proficiency with Selenium/WebDriver and Playwright, including framework design and stability techniques.
• Experience designing and maintaining end-to-end automation frameworks for complete workflows and system integrations.
• Experience with AI-assisted testing tools and LLM-driven test generation/triage.
• Experience with API testing tools (REST Assured, Postman, Karate) and contract testing concepts.
• CI/CD integration and cloud environments (e.g., AWS).
• Familiarity with DICOM and HL7 protocols and data interoperability.
• Experience supporting RA/QA during regulatory audits.

Responsibilities

• Design, implement, and maintain end-to-end automated test suites across UI, API, and back-end services.
• Champion AI-first automation strategy and AI-assisted test authoring.
• Build daily smoke/build-acceptance tests across dev and staging environments.
• Lead post-deployment testing, production smoke tests, and live-environment verification.
• Create golden-dataset regression tests for ML pipelines.
• Automate tests for 3D Web Viewer and UIs with visual regression.
• Write clear test plans, protocols, and traceability documents.
• Validate test infrastructure per QMS procedures and standards.
• Build UI automation with Selenium and Playwright and improve stability.
• Coordinate API/integration tests across teams with REST/contract testing.
• Translate requirements into verifiable test cases with traceability.
• Triage failures and contribute to defect prevention.
• Contribute to CI/CD with fast, actionable feedback.
• Support audits with test evidence and documentation.
• Mentor junior testers and help scale the team.

Skills

Selenium/WebDriver

Playwright

AI-assisted testing

API testing

CI/CD

DICOM/HL7

Test planning

Regulated testing

Education

Bachelor's degree in CS/Engineering

Tools

REST Assured

Postman

Karate

Ketryx/Jama/Polarion

GitHub Actions

Harness

AWS

Job description

HeartFlow, Inc. is recruiting a Senior Test Engineer to drive end-to-end automated testing across UI, API, and ML pipelines for our SaMD products.

The role focuses on building AI-assisted automation, validating medical device software under QMS, and scaling the test program with offshore teams and contractors. You will design and maintain E2E automation, develop golden datasets for ML validation, and ensure traceability from requirements to evidence in a regulated environment.