About The Company Cleerly is a pioneering healthcare organization dedicated to transforming the diagnosis, treatment, and management of heart disease through innovative, AI-driven solutions. Founded in 2017 by a renowned cardiologist, the company has rapidly grown into a leader in the field, backed by substantial funding including $223 million in Series C in 2022 and an additional $106 million in a Series C extension in December 2024. With a commitment to advancing cardiovascular care, Cleerly develops comprehensive, value-based diagnostic tools that leverage advanced imaging and artificial intelligence to provide detailed insights into atherosclerosis and plaque buildup within the heart arteries. Our team comprises top-tier professionals across engineering, medical sciences, operations, marketing, and sales, many working remotely from locations such as Denver, New York, Dallas, and Lisbon. Our mission is to prevent heart attacks by establishing a new standard of precision, early detection, and personalized care, supported by extensive clinical research and rigorous validation processes.

About The Role We are seeking a highly experienced Staff Software Quality Engineer (SQE) to join our core technical team focused on our next-generation enterprise imaging platform. This role is pivotal in ensuring the quality, safety, and regulatory compliance of our software solutions, particularly in the regulated healthcare IT and medical imaging sectors. The ideal candidate will be responsible for overseeing all aspects of quality assurance throughout the entire software development lifecycle, from initial design to deployment and maintenance. This includes developing and executing comprehensive testing strategies, driving automation efforts, and collaborating closely with engineering, clinical, and regulatory teams to embed quality into every phase of product development. The role demands a hands-on approach, deep expertise in validating cloud-based AI medical imaging products, and familiarity with modern automation frameworks. The successful candidate will play a critical role in maintaining compliance with industry standards such as FDA regulations, ISO 13485, IEC 62304, and healthcare data standards like DICOM, HL7, and FHIR. This position offers the opportunity to impact healthcare on a global scale by ensuring the delivery of reliable, safe, and effective medical software solutions.

Qualifications

• Bachelor’s degree in Computer Engineering, Electrical & Electronics Engineering, or related fields.
• 10+ years of experience in regulated Software Quality Assurance (SQA), specifically within SaMD (Software as a Medical Device) environments.
• Extensive experience with the full verification and validation (V&V) lifecycle and preparing evidence for FDA 510(k), De Novo, or PMA submissions.

Responsibilities

• Lead and own the quality and validation program for the new Hub product stream and associated integrations.
• Establish and enforce a risk-based, automation-first test strategy focusing on APIs and asynchronous workflows.
• Develop comprehensive test plans, complex data sets, and detailed test cases for next-generation products.

Benefits

• Competitive salary aligned with market benchmarks, with consideration for location and experience.
• Target annual bonus of 15%, with total compensation including base salary, bonuses, and stock options.
• Comprehensive health, dental, and vision insurance plans designed to meet diverse needs.
• 401(k) retirement plan to support long-term financial planning.
• Equity participation through employee stock options, fostering ownership and shared success.
• Opportunities for professional growth through Cleerly U and exposure to cutting-edge healthcare technology.
• Flexible work arrangements with remote work options and occasional travel for team meetings and cross-functional projects.

Equal Opportunity

We are proud to be an Equal Employment Opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, veteran status, or any other basis protected by federal, state, or local law.