Software Quality Engineer

Overview

About Cleerly We’re Cleerly – a healthcare company revolutionizing how heart disease is diagnosed, treated, and tracked. Founded in 2017 by a world-class cardiologist, we are a growing team of engineering, operations, medical affairs, marketing, and sales leaders. We have raised $223M in Series C funding in 2022 and an additional $106M in a Series C extension funding in December 2024.

Most teams work remotely with access to offices in Denver, CO;
New York, NY;
Dallas, TX; and Lisbon, Portugal, with some roles requiring on-site presence.

Cleerly has created a new standard of care for heart disease through value-based, AI-driven precision diagnostic solutions aimed at preventing heart attacks. Our technology enables comprehensive quantification and characterization of atherosclerosis in the heart arteries and is supported by a decade of clinical trial work to identify findings beyond symptoms that affect risk of heart attacks.

We collaborate digitally and use a range of tools (Google Workspace, Slack, Confluence/Jira, Zoom). Role-specific technology needs may vary and will be listed as requirements in the job description. Travel may be required for some meetings and cross-functional projects, typically once per month or per quarter (in some roles up to 90% travel).

We are seeking an experienced Staff-level Software Quality Engineer (SQE) to join the core technical team of our next-generation enterprise-level imaging platform. The Staff SQE will own all aspects of quality throughout the software development lifecycle, develop and drive automation, and support regulatory requirements for the platform.

Responsibilities

• Lead Quality Program:
  Own the quality and validation program for the new Hub product stream and its partner integrations.
• Define Test Strategy:
  Establish and enforce a risk-based, automation-first test strategy focusing on APIs and asynchronous workflows.
• Ensure Clinical Rigor:
  Build clinical-grade end-to-end validation for reporting/write-back and establish release gates with full traceability.
• Maintain Compliance:
  Partner with engineering and regulatory teams to maintain SaMD-grade rigor, QMS compliance, and audit readiness.
• Develop Test Assets:
  Create comprehensive test plans, data sets, and detailed test cases for next-generation products.
• Drive Automation:
  Develop, maintain, and improve test automation and regression tests; architect automated reporting pipelines that generate 21 CFR Part 11 compliant evidence and traceability from test execution.
• Execute Validation:
  Perform end-to-end manual system validation and exploratory testing across the platform.
• API and Service Testing:
  Test APIs and backend services for conformity with technical specifications.
• Manage Defects:
  Prioritize defects and perform impact analysis to ensure timely resolution.
• Advocate for Quality:
  Act as a Quality Bar-Raiser, participating in design and planning to embed quality early in development.

Requirements

• 10+ years in regulated SQA with SaMD experience, including full V&V lifecycle and authoring evidence for FDA 510(k), De Novo, or PMA submissions.
• SDET-level engineering:
  Proficiency in Python, Java, or C# to build automation frameworks, API test suites, and End-to-End harnesses that simulate complex clinical environments (PACS/EHR).
• Regulatory Dev Ops:
  Hands-on experience implementing Traceability-as-Code and automated compliance checks within CI/CD pipelines.
• Standards & Interoperability:
  Deep knowledge of healthcare data standards (DICOM, HL7, FHIR) and medical device software standards (ISO 13485, IEC 62304).
• Audit & Change Management:
  Expertise in change control, impact assessments, and audit-ready validation packages (trace matrices, protocols, and reports).
• Cross-Functional Leadership:
  Ability to bridge Engineering, Clinical, and Regulatory teams to define and enforce the Definition of Done.

Nice-to-have

• Structured Reporting Validation:
  Familiarity with DICOM Structured Reporting workflows including DICOM-SR, SEG, and PR objects.
• SaMD Security Testing:
  Experience with security testing and producing SaMD security documentation (threat modeling inputs and vulnerability management evidence).

Educatio…