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Salary: USD 190,000 - 250,000 / annual
HeartFlow is a publicly traded medical technology company (HTFL) pioneering AI-driven solutions for coronary artery disease diagnosis and management. The company's flagship product, HeartFlow FFR_CT Analysis, is a non-invasive cardiac test cleared for use in the US, UK, Europe, Japan, and Canada, and has been deployed across more than 750,000 patients worldwide.
The Test Architect is a senior technical leader and founding hire for HeartFlow's Test Engineering function. This is a hands-on Staff/Principal-level individual contributor role responsible for architecting the end-to-end testing framework and automation pipeline across the company's regulated Software as a Medical Device (SaMD) products. The role partners closely with the Director of Test Engineering and engineering leadership to set technical direction for automated testing, post-deployment verification, and tool validation.
Key responsibilities include:
- Setting and evolving technical strategy for end-to-end test automation across the full product pipeline, defining patterns, frameworks, and architecture that scale.
- Driving an AI-first approach to test automation: defining how AI-assisted authoring, self-healing locators, AI-generated spec-driven test development, and LLM-driven triage are adopted and rolled out.
- Architecting post-deployment testing capabilities including production smoke tests, synthetic monitoring, and continuous validation against live environments.
- Designing test depth and rigor calibrated to each software component's safety classification, ensuring higher-risk components receive deeper verification.
- Authoring complex test plans, protocols, and reports; setting standards and templates for the organization under the QMS.
- Leading tool validation strategy for test infrastructure and automation tooling in partnership with RA/QA to meet regulatory expectations.
- Architecting, building, and improving UI and mobile automation using Selenium, Playwright, and other frameworks, including WebGL-based 3D viewers and desktop clinical applications.
- Defining API and integration testing standards using REST Assured, Postman, Karate, and contract testing approaches.
- Establishing testing standards for medical imaging, clinical data interoperability protocols, and report/document output validation.
- Partnering with engineering, product, and RA/QA leaders to translate complex requirements into verifiable test strategies with full traceability.
- Owning the technical relationship between requirements management and traceability tooling, ensuring every automated test maps to documented requirements.
- Leading root-cause investigations on high-impact issues across distributed systems and driving systemic prevention.
- Defining how automated tests integrate into CI/CD to deliver fast, reliable feedback to engineering teams.
- Serving as primary technical owner for quality-related audits, CAPAs, and regulatory submissions, providing test evidence and documentation.
- Mentoring senior and mid-level engineers; leading technical reviews and raising the bar on quality engineering practices.
- Helping define hiring profiles and leading technical interviews for future Test Engineering hires.
- Influencing cross-functional decisions on quality strategy, tooling investments, and engineering process improvements.
REQUIREMENTS:
- 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 (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 (AI-augmented authoring, self-healing automation, LLM-driven test generation or triage).
- Strong programming skills in at least one mainstream language used for automation (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 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 (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.
