Test Architect

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

Job summary

Heartflow is seeking a Test Architect to lead end-to-end automated testing for its SaMD products. This senior role shapes the test framework across frontend, backend, 3D modeling, and AI/ML systems, ensuring compliance with medical device QMS and regulatory standards.

The candidate will drive AI-assisted testing strategies, build scalable automation, and align testing with CI/CD and regulatory audits. Collaboration with RA/QA and engineering leadership is essential.

Qualifications

• Experience testing Software as a Medical Device (SaMD) or regulated medical device software with test strategy ownership.
• Deep knowledge of medical device QMS practices and standards (ISO 13485, IEC 62304, ISO 14971, 21 CFR Part 820).
• Expert in automation frameworks with large-scale stability and parallel execution.

Responsibilities

• Set and evolve the technical strategy for end-to-end test automation across Heartflow's pipeline.
• Drive AI-first test automation strategies including AI-assisted authoring and LLM-driven triage.
• Architect and own post-deployment testing capabilities including production smoke and synthetic monitoring.
• Design test depth aligned to software component safety classifications and provide evidence.
• Author complex test plans, protocols, and reports under QMS.
• Lead tool validation strategy and ensure regulatory evidence.
• Architect and improve UI and mobile automation across Selenium and Playwright.
• Define API and integration testing standards.

Skills

Automation frameworks

SDET leadership

Regulated SaMD

Selenium WebDriver

Playwright

QA QMS

CI/CD

Python

Education

Bachelor's degree in Computer Science/Engineering or related field

Tools

Selenium

Playwright

REST Assured

Postman

Job description

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting‑edge technology. The flagship product—an AI‑driven, non‑invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFRCT Analysis—provides a color‑coded, 3D model of a patient’s coronary arteries indicating the impact blockages have on blood flow to the heart. Heartflow is the first AI‑driven non‑invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMap™Analysis), assess coronary blood flow (FFRCT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis).

Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare.

Heartflow is a publicly traded company (HTFL) that has received international recognition for exceptional strides in healthcare innovation, is supported by medical societies around the world, cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 500,000 patients worldwide.

The Test Architect is a senior individual contributor and technical leader on the Test Engineering team. This role sets the technical direction for end‑to‑end automated testing, post‑deployment verification, and tool validation across our regulated SaMD products, partnering closely with the Director of Test Engineering and engineering leadership. The Test Architect drives our AI‑first test automation strategy designing how AI‑assisted authoring, self‑healing automation, and LLM‑driven triage are applied at scale while ensuring all activities meet the rigor of a medical device QMS. This is the founding technical hire for Heartflow's Test Engineering function, responsible for architecting the end‑to‑end testing framework across frontend, backend, 3D modeling, and AI/ML systems, and for building the automation pipeline the rest of the team will be hired and scaled against. The ideal candidate brings deep technical expertise in modern automation frameworks (Selenium and Playwright), a strong track record shipping regulated SaMD products, and the ability to influence engineers and leaders across the organization.

Responsibilities

• Set and evolve the technical strategy for end‑to‑end (E2E) test automation across Heartflow's full pipeline, defining patterns, frameworks, and architecture that scale with the platform.
• Drive the AI‑first approach to test automation: define how AI‑assisted authoring, self‑healing locators, AI generated spec driven test development and LLM‑driven triage are adopted, evaluated, and rolled out across teams.
• Architect and own post‑deployment testing capabilities, including production smoke, synthetic monitoring, and continuous validation against live environments.
• Design test depth and rigor calibrated to each software component's safety classification, ensuring higher‑risk components receive deeper verification and evidence.
• Author the most complex and consequential test plans, protocols, and reports; set the standards and templates other engineers follow under our QMS.
• Lead tool validation strategy for test infrastructure and automation tooling, partnering with RA/QA to ensure validation evidence meets regulatory expectations.
• Architect, build, and continually improve UI and mobile automation including but not limited to Selenium and Playwright — driving stability, parallelism, observability, and reuse across products, including our WebGL‑based 3D viewer and desktop clinical applications.
• Define API and integration testing standards using tools such as REST Assured, Postman, Karate, and contract testing where appropriate.
• Define testing standards for medical imaging and clinical data interoperability protocols, and for report/document output validation.
• Partner with engineering, product, and RA/QA leaders to translate complex requirements into verifiable test strategies with full traceability.
• Own the technical relationship between requirements management and traceability tooling, ensuring every automated test maps to a documented requirement and audit‑ready evidence.
• Lead deep root‑cause investigations on the highest‑impact issues across distributed systems and drive systemic prevention of recurrence.
• Define how automated tests are integrated into CI/CD to deliver fast, reliable, actionable feedback to engineering teams.
• Serve as a primary technical owner for quality‑related audits, CAPAs, and regulatory submissions, providing test evidence, traceability, and documentation.
• Mentor senior and mid‑level engineers; lead technical reviews, raise the bar on quality engineering practices, and grow the team's technical depth.
• Help define hiring profiles and lead technical interviews for future Test Engineering hires and contractor partners.
• Influence cross‑functional decisions on quality strategy, tooling investments, and engineering process improvements.

Qualifications

• 8–12 years of experience in software test engineering, SDET, or quality engineering roles, with a strong record as a hands‑on technical leader who has personally architected automation frameworks.
• Required: Substantial experience testing Software as a Medical Device (SaMD) or other regulated medical device software, including ownership of test strategy on shipped products.
• Required: Deep working knowledge of medical device QMS practices and applicable standards (e.g., ISO 13485, IEC 62304, ISO 14971, 21 CFR Part 820), including test documentation, traceability, tool validation, and audit support.
• Required: Expert‑level proficiency with Selenium / WebDriver and Playwright, including framework architecture, large‑scale stability and flake reduction, and parallel execution at scale.
• Track record designing, scaling, and maintaining E2E automation frameworks covering complete workflows and complex system integrations.
• Experience setting test plan, protocol, and report standards in a regulated environment, with rigorous traceability across requirements, test cases, and evidence.
• Demonstrated leadership in adopting AI‑assisted testing tools and techniques (e.g., AI‑augmented authoring, self‑healing automation, LLM‑driven test generation or triage).
• Strong programming skills in at least one mainstream language used for automation (e.g., Python, TypeScript/JavaScript, Java, or C#); able to set coding standards for the test organization.
• Deep experience with API and contract testing approaches (REST Assured, Postman, Karate, Pact, or equivalent).
• Strong experience integrating automated tests into CI/CD pipelines and working with cloud environments such as AWS.
• Excellent analytical and debugging skills across distributed systems; able to participate in root‑cause investigations on the most complex failures.
• Excellent written and verbal communication skills; able to influence engineers, leaders, and cross‑functional partners.
• Bachelor's degree in Computer Science, Engineering, or a related field, or equivalent practical experience.

Desired

• Direct experience with requirements/traceability tooling such as Ketryx, Jama, or Polarion.
• Experience with DICOM and/or HL7 protocols, or other clinical data interoperability standards.
• Experience leading RA/QA partnerships during regulatory audits and inspections.
• Experience defining test strategy for ML/AI systems, clinical validation workflows, or medical imaging products.
• Experience validating complex visualizations (qualitative and quantitative) such as 3D models, overlays, and measurement views.
• Experience automating legacy desktop applications (e.g., Windows/C++) using tools such as WinAppDriver.
• Experience designing and managing diverse test datasets (synthetic, anonymized, adversarial).
• Experience defining non‑functional / performance testing strategy with tools such as k6, Locust, JMeter, or Gatling.
• Experience with data‑pipeline testing and microservices architectures at scale.
• Demonstrated ability to define, own, and evolve actionable quality metrics.

A reasonable estimate of the base salary compensation range is $190,000 to $250,000, bonus, and equity. #LI-IB1

Heartflow is an Equal Opportunity Employer. We are committed to a work environment that supports, inspires, and respects all individuals and do not discriminate against any employee or applicant because of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. This policy applies to every aspect of employment at Heartflow, including recruitment, hiring, training, relocation, promotion, and termination.