AI-Driven Test Architect for SaMD

Heartflow; San Francisco (CA); On-site; USD 190,000 - 250,000; Full time

Job summary

Heartflow is hiring a Test Architect to lead end-to-end automated testing for its AI-driven SaMD platform. You will define the testing strategy across frontend, backend, 3D modeling, and AI/ML systems, ensuring regulatory compliance and traceability.

The role requires 8–12 years in test engineering, deep knowledge of ISO 13485/62304/14971, and expert use of Selenium and Playwright to scale tests while partnering with RA/QA to validate tools and processes.

Qualifications

• 8–12 years of experience in software test engineering or quality engineering, with hands-on leadership.
• Experience testing SaMD or regulated medical device software, owning test strategy for shipped products.
• Deep knowledge of medical device QMS practices and standards (ISO 13485, IEC 62304, ISO 14971, 21 CFR Part 820).
• Expert proficiency with Selenium/WebDriver and Playwright, scalable, parallel test execution.
• Experience designing, scaling, and maintaining end-to-end automation across frontend, backend, 3D modeling, and AI/ML.
• Strong programming skills in at least one language (Python/TypeScript/Java/JavaScript/C#).
• Experience API/contract testing (REST Assured, Postman, Karate) and CI/CD integration.
• Familiarity with cloud environments (AWS) and data interoperability protocols (DICOM/HL7) is a plus.

Responsibilities

• Set and evolve the technical strategy for end-to-end test automation across the full pipeline.
• Drive AI-first testing approaches, including AI-assisted authoring and LLM-driven triage.
• Own post-deployment testing capabilities, production smoke, synthetic monitoring, and validation against live environments.
• Define testing standards and traceability to requirements with audit-ready evidence.
• Lead tool validation strategy and drive regulatory-grade validation with RA/QA colleagues.
• Architect and improve UI and mobile automation including Selenium and Playwright across WebGL 3D viewer and desktop apps.
• Integrate automated tests into CI/CD and inform quality metrics across distributed systems.

Skills

Selenium

Playwright

QA leadership

Python

Regulated SaMD

CI/CD

Education

Bachelor's degree in Computer Science or Engineering

Tools

REST Assured

Postman

Karate

Job description

Heartflow is hiring a Test Architect to lead end-to-end automated testing for its AI-driven SaMD platform. You will define the testing strategy across frontend, backend, 3D modeling, and AI/ML systems, ensuring regulatory compliance and traceability.

The role requires 8–12 years in test engineering, deep knowledge of ISO 13485/62304/14971, and expert use of Selenium and Playwright to scale tests while partnering with RA/QA to validate tools and processes.