Staff Test Engineer

The Staff Test Engineer 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 Engineering in Test and engineering leadership. The Staff Test Engineer 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. 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 product lines, 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, generative test design, 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.
• 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 automation in Selenium, Vitest and Playwright — driving stability, parallelism, observability, and reuse across products.
• Define API and integration testing standards using tools such as REST Assured, Postman, Karate, and contract testing where appropriate.
• Partner with engineering, product, and RA/QA leaders to translate complex requirements into verifiable test strategies with full traceability.
• 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.
• 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.
• 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., TypeScript/JavaScript, Python, 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 lead 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

• 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 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