Senior QA Engineer

What you'll own

• Test strategy and planning. Author test plans for new features, releases, and customer deployments — defining scope, risk-based prioritization, entry/exit criteria, environments, and data requirements — so that "tested" means the same thing to Engineering, Clinical, and Quality.
• Rigorous, exhaustive test case design. Build test suites that cover the platform's full behavior surface: boundary conditions, failure-mode handling, degraded-network behavior from facilities we don't control, malformed HL7 v2 and FHIR payloads, timezone and identity edge cases across EHR integrations (PointClickCare, Homecare Homebase, WellSky), and the alert-delivery paths where reliability matters most.
• Compliance-grade test reporting. Write comprehensive, detailed test reports and verification & validation documentation suitable for our Design History File, regulatory submissions (510(k)), and ISO 13485 / FDA QMSR audits — including requirements-to-test traceability matrices, defect trending, and evidence packages, in partnership with our Design Quality team.
• Automation and scripting. Build and maintain automated regression, API, and UI test suites in Python (PyTest) against our FastAPI services and React applications, integrated into CI/CD so every merge to production runs the full safety net. Script the tooling — test data generation, environment setup, synthetic device telemetry — that makes thorough testing fast.
• Regression protection. Own the release-readiness signal: a regression suite the team trusts, flaky-test triage, and a clear verdict on every release candidate.
• Quality culture. Champion testability across the engineering org — reviewing designs for verifiability, partnering with engineers on test coverage, and reinforcing quality as a property of how we build.

How success is measured

• Release quality: every release candidate ships with a clear, evidence-backed readiness verdict.
• Regression suite coverage and reliability: high coverage of critical paths, low flake rate, trusted by the team as a release gate.
• Audit readiness: test documentation accepted into the DHF and regulatory submissions without rework.
• Release velocity: automation reduces, not adds to, time from merge to production.

Required Qualifications

• 5+ years in software QA, SDET, or test engineering roles, with ownership of quality for at least one significant production system
• Demonstrated experience authoring formal test plans and designing systematic, exhaustive test cases (boundary analysis, equivalence partitioning, risk-based and negative testing)
• Experience producing detailed test reports and V&V documentation in a medical device, healthcare, or other highly regulated environment (FDA, ISO 13485, IEC 62304, or comparable)
• Strong Python scripting and hands-on automation experience with PyTest or similar frameworks, including API testing and UI automation (Playwright, Selenium, or equivalent)
• Experience testing integrations with third-party systems you do not control
• Strong SQL and comfort validating data across relational databases and warehouses
• Experience integrating automated tests into CI/CD pipelines

Preferred

• Software as a Medical Device (SaMD) verification, IEC 62304 software lifecycle documentation, or direct contribution to a 510(k) or CE submission
• Healthcare data and integration testing: HL7 v2, FHIR, ADT feeds, EHR vendor systems
• HIPAA / SOC 2 environments and sound PHI handling in test data
• Performance, load, or telemetry-ingestion testing at IoT scale
• Significant open source, systems that outlived your tenure, or a high-bar engineering background