Cleerly · 2 hours ago
Staff Software Quality Engineer
Denver, CO
Full-time
Hybrid
Senior Level, Lead/Staff
$137K/yr - $160K/yr
10+ years expCleerly is a healthcare company revolutionizing heart disease diagnosis and treatment through AI-driven precision diagnostic solutions. They are seeking a Staff Software Quality Engineer responsible for ensuring quality control throughout the software development life cycle, developing testing methods, and driving automation efforts.
AppsArtificial Intelligence (AI)Health CareMedicalWellness
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 async workflows
Ensure Clinical Rigor: Build clinical-grade end-to-end validation for reporting/write-back and establish release gates with complete 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, complex data sets, and detailed test cases for next-generation products
Drive Automation: Lead efforts to enhance testing efficiency through the development, maintenance, and improvement of test automation and regression tests. Architect automated reporting pipelines that generate 21 CFR Part 11 compliant evidence and traceability matrices directly 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 to ensure compliance with technical specifications
Manage Defects: Drive defect prioritization and perform thorough impact analysis to ensure resolution
Advocate for Quality: Act as the Quality Bar-Raiser, participating in design and planning to embed quality early in the development lifecycle
Qualification
Required
10+ Years in Regulated SQA: Extensive experience in SaMD (Software as a Medical Device), including the full V&V lifecycle and authoring evidence for FDA 510(k), De Novo, or PMA submissions
SDET-Level Engineering: High proficiency in at least one language (Python, Java, or C#) to build custom automation frameworks, API test suites, and E2E harnesses that simulate complex clinical environments (PACS/EHR)
Regulatory DevOps: Hands-on experience implementing 'Traceability-as-Code,' integrating automated compliance checks, and managing release gates within a CI/CD pipeline
Standards & Interoperability: Deep knowledge of healthcare data standards (DICOM, HL7, FHIR) and medical device software standards (ISO 13485, IEC 62304)
Audit & Change Management: Expert at navigating change control, performing impact assessments, and producing audit-ready validation packages (Trace Matrices, Protocols, and Reports)
Cross-Functional Leadership: Proven ability to bridge the gap between Engineering, Clinical, and Regulatory teams to define and enforce the 'Definition of Done.'
Deep experience validating cloud-based AI medical imaging products
Familiarity with modern test automation tools and frameworks
Essential soft skills including being a highly motivated self-starter, detail-oriented, a strong team player, and demonstrating ownership, accountability, and commitment to high-quality deliverables
Bachelor's degree in Computer Engineering, Electrical & Electronics Engineering, or related fields
Preferred
Structured Reporting Validation: Familiarity and experience with the validation of DICOM Structured Reporting workflows, specifically including DICOM-SR, SEG, and PR objects
SaMD Security Testing: Proven experience with security testing and producing required SaMD security documentation (e.g., contributing threat modeling inputs and compiling vulnerability management evidence)
Benefits
15% target annual bonus
Stock options
Paid benefits
Employee perks
Company
Cleerly
Cleerly is a digital healthcare company that offers heart disease diagnosis solutions.
201-500 employees
H1B Sponsorship
Cleerly has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (2)
2023 (1)
2022 (1)
2021 (3)
2020 (2)
Funding
Current Stage
Growth StageTotal Funding
$386.48MKey Investors
Insight PartnersVensana Capital
2024-12-03Series C· $106M
2022-07-25Series C· $223M
2021-06-21Series B· $43M
Leadership Team
James Min
Founder and Chief Executive Officer
Jim Hartman
Chief Commercial Officer (CCO)
Recent News
2026-01-07
2025-11-27
Company data provided by crunchbase