Staff Software Quality Engineer

Cleerly • Denver, CO

12d • Remote

About The Position

We are seeking an experienced, Staff-level Software Quality Engineer (SQE) to join the core technical team of our growing next-generation enterprise-level imaging platform. This individual will be the Staff SQ Engineer, responsible for all aspects of quality control throughout the entire software development life cycle. This includes continual development and implementation of rigorous testing methods and procedures to evaluate the software's quality. He or she will be expected to develop and drive automation methods while actively assisting the platform development team in fulfilling its crucial Quality and Regulatory requirements. We require a hands-on Staff SQ engineer with prior experience in this role within the regulated healthcare IT and medical imaging industries. The ideal candidate must possess: 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.

Requirements

• 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."

Nice To Haves

• 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).

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.

Benefits

• Cleerly offers a variety of medical, dental, and vision plans, designed to fit you and your family’s needs.
• Our 401(k) program helps you invest in the future.
• Everyone on the team contributes to our success, so everyone has equity in the company through our employee stock option incentive plan.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees