Clinical Test Engineer Jobs in California (NOW HIRING)

The Senior Test Engineer is a hands-on individual contributor on the Test Engineering team, responsible for end-to-end system testing, post-deployment verification, and the design and execution of automated test suites that protect the quality of our regulated SaMD products. Working under the technical direction set by the Test Architect, this role takes primary ownership of building out automated coverage across HeartFlow's pipeline from the ML/AI algorithms and clinical computation services through the Workstation, web applications, and reporting layers while applying the rigor required of a medical device environment. This role also plays a key part in scaling the team, supporting and coordinating offshore/contractor test engineers as HeartFlow's automation program grows. The ideal candidate brings deep technical expertise in modern UI automation frameworks (Selenium and Playwright), experience writing test plans and validating tools under a QMS, and a track record of shipping high-quality software in a regulated SaMD context.

Responsibilities

• Design, implement, and maintain end-to-end (E2E) automated test suites that exercise complete user workflows across UI, API, and back-end services, executing against the architecture and standards set by the Test Architect.
• Champion an AI-first automation strategy. Implement and scale test coverage using AI-assisted authoring and generative test planning derived from AI-generated requirements, while leveraging intelligent triage to minimize maintenance overhead.
• Build and own a baseline suite of daily smoke/build-acceptance tests covering core workflows across development and staging environments, closing a current gap where automated testing only runs during formal V&V cycles.
• Lead post-deployment testing activities, including production smoke tests, monitoring-driven verification, and continuous validation against live environments.
• Design and implement golden-dataset regression tests for HeartFlow's ML pipeline services, validating algorithmic outputs against curated reference cases.
• Build automated test coverage for HeartFlow's WebGL-based 3D Web Viewer and Clinical/CaseOps UIs using Playwright, including visual regression for 3D model rendering and view generation.
• Author clear, traceable test plans, test protocols, and test reports that meet the documentation expectations of a regulated medical device QMS.
• Perform tool validation for test infrastructure and automation tooling in accordance with internal QMS procedures and applicable standards.
• Build and maintain UI automation using Selenium and Playwright; extend frameworks for stability, parallelism, and reuse across product lines.
• Collaborate with software engineering teams to standardize API-level and integration tests using tools such as REST Assured, Postman, or Karate, including testing for DICOM ingestion and HL7 output validation at the hospital/cloud boundary.
• Partner with software engineers, product managers, and RA/QA to translate requirements into verifiable test cases with full traceability, contributing to closing the current gap between code commits and Ketryx-generated audit evidence.
• Triage and root-cause failures across complex distributed systems; drive defects to resolution and contribute to defect-prevention initiatives.
• Contribute to CI/CD pipelines so that automated tests run reliably and provide fast, actionable feedback to engineering teams.
• Support quality-related audits, CAPAs, and regulatory submissions by providing test evidence, traceability, and documentation.
• Support and coordinate offshore/contractor test engineers for overlapping product areas, helping ramp them on HeartFlow's systems and test standards.
• Mentor the Test Engineer role and contribute to hiring as the team scales.

Qualifications

• 5-8 years of experience in software test engineering, SDET, or quality engineering roles, with a strong hands-on automation background.
• Required: Direct experience testing Software as a Medical Device (SaMD) or other regulated medical device software.
• Required: 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, and tool validation.
• Required: Strong proficiency with Selenium / WebDriver and Playwright, including framework design, page-object patterns, and stability/flake reduction techniques.
• Demonstrated experience designing and maintaining E2E automation frameworks that cover complete workflows and system integrations.
• Experience authoring test plans, protocols, and reports in a regulated environment, with attention to traceability between requirements, test cases, and evidence.
• Practical experience with AI-assisted testing tools and techniques (e.g., AI-augmented test authoring, self-healing automation, LLM-driven test generation or triage).
• Solid programming skills in Python and at least one additional mainstream language used for automation (e.g., TypeScript/JavaScript, Java, or C#).
• Experience with API testing tools (REST Assured, Postman, Karate, Pact.io or equivalent) and basic familiarity with contract testing concepts.
• Experience integrating automated tests into CI/CD pipelines (e.g., GitHub Actions, Harness) and working with cloud environments such as AWS.
• Strong analytical and debugging skills across distributed systems, with a structured approach to root-cause analysis.
• Excellent written and verbal communication skills; able to clearly document test designs, defects, and risk.
• 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 supporting RA/QA teams during regulatory audits and inspections.
• Experience testing ML/AI systems, clinical validation workflows, or medical imaging products, including statistical or tolerance-based regression approaches.
• Experience validating complex visualizations (qualitative and quantitative) such as 3D models, overlays, or measurement views.
• Experience generating and managing diverse test datasets (synthetic, anonymized, adversarial).
• Experience coordinating or mentoring offshore or contractor test engineers.
• Familiarity with non-functional / performance testing tools (e.g., k6, Locust, JMeter, Gatling).
• Exposure to data-pipeline testing and microservices architectures.
• Contributions to defining and tracking actionable quality metrics.

A reasonable estimate of the base salary compensation range is $165,000 to $205,000, bonus, and equity. #LI-IB1