Senior Test Engineer

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. This role takes an AI-first approach to test automation — using AI-assisted tooling to accelerate test authoring, triage, and maintenance — while applying the rigor required of a medical device environment. 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.
• Apply an AI-first approach to test automation: leverage AI-assisted authoring, self-healing locators, intelligent test triage, and generative techniques to scale coverage and reduce maintenance burden.
• Lead post-deployment testing activities, including production smoke tests, monitoring-driven verification, and continuous validation against live environments.
• 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, Vitest 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, and contribute to contract testing where appropriate.
• Partner with software engineers, product managers, and RA/QA to translate requirements into verifiable test cases with full traceability.
• 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 offshore test engineers for overlapping product areas.

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 at least one mainstream language used for automation (e.g., TypeScript/JavaScript, Python, Java, or C#).
• Experience with API testing tools (REST Assured, Postman, Karate, 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

• Experience supporting RA/QA teams during regulatory audits and inspections.
• Experience testing ML/AI systems, clinical validation workflows, or medical imaging products.
• 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).
• 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