Staff Software Quality Engineer

About Cleerly

We’re Cleerly – a healthcare company that’s revolutionizing how heart disease is diagnosed, treated, and tracked. We were founded in 2017 by one of the world’s leading cardiologists and are a growing team of world-class engineering, operations, medical affairs, marketing, and sales leaders. We raised $223M in Series C funding in 2022 which has enabled rapid growth and continued support of our mission. In December 2024 we received an additional $106M in a Series C extension funding. Most of our teams work remotely and have access to our offices in Denver, Colorado, New, York, New York, Dallas, Texas, and Lisbon, Portugal with some roles requiring you to be on-site in a location.

Cleerly has created a new standard of care for heart disease through value-based, AI-driven precision diagnostic solutions with the goal of helping prevent heart attacks. Our technology goes beyond traditional measures of heart disease by enabling comprehensive quantification and characterization of atherosclerosis, or plaque buildup, in each of the heart arteries. Cleerly’s solutions are supported by more than a decade of performing some of the world’s largest clinical trials to identify important findings beyond symptoms that increase a person’s risk of heart attacks.

At Cleerly, we collaborate digitally and use a wide variety of systems. Our people use Google Workspace (GMail, Drive, Docs, Sheets, Slides), Slack, Confluence/Jira, and Zoom Video, prior experience in these areas is a plus. Role or department specific technology needs may vary and will be listed as requirements in the job description.

While we are mostly a remote company, travel is required for some team meetings and cross function projects typically once per month or once per quarter, for some roles like sales or external facing roles travel could be up to 90% of the time.

About the Opportunity

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.

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.

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-have

• 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).

Education

• Bachelor’s degree in Computer Engineering, Electrical & Electronics Engineering, or related fields.

Why you should apply:

• PURPOSE: Cleerly’s purpose is to create a world without heart attacks. With our new paradigm for precision heart care, we will leave big footprints in the sands of time. Help us make that a reality!

• COMMUNITY: We are building a truly world class team of talented problem solvers. While we have diverse backgrounds, we are united in our commitment to each other, to our customers, and to the patients our technology serves.

• GROWTH: We prioritize learning and growth. As a rapid growth company, there is always space for new challenges and responsibilities. And, through Cleerly U, we invest in the development of our team.

• OWNERSHIP: Everyone on the team contributes to our success, so everyone has equity in the company through our employee stock option incentive plan.

• 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.

Impress Us More…

• Experience working in healthcare or another heavily-regulated industry.

• Experience working in a start-up environment.

Compensation:

The base salary range for this role varies by location and is aligned to market benchmarks.

• Candidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range.

• Final compensation is determined based on location, experience, skills, and internal equity.

This role is eligible for a 15% target annual bonus, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $163,000 - $190,000

• TTC*: $187,000 - $218,000

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.

Working at Cleerly takes HEART. Discover our Core Values:

• H: Humility- be a servant leader

• E: Excellence- deliver world-changing results

• A: Accountability- do what you say; expect the same from others

• R: Remarkable- inspire & innovate with impact

• T: Teamwork- together we win

Don’t meet 100 percent of the qualifications? Apply anyway and help us diversify our candidate pool and workforce. We value experience, whether gained formally or informally on the job or through other experiences. Job duties, activities and responsibilities are subject to change by our company.

OUR COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER. We do not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law, ordinance, or regulation.

By submitting your application, you agree to receive SMS messages from Cleerly recruiters throughout the interview process. Message frequency may vary. Message and data rates may apply. You can STOP messaging by sending STOP and get more help by sending HELP. For more information see our Privacy Policy (https://cleerlyhealth.com/privacy-policy). All official emails will come from @cleerlyhealth.com email accounts.

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