Imagen is extending the frontiers of medicine and artificial intelligence to improve human well-being. Our mission is to reduce diagnostic errors early in the patient experience while making care more affordable and accessible. We’re a team of leading scientists, engineers, clinicians, and industry professionals from some of the top healthcare and technology organizations across the globe. Our clinical team is composed of radiologists and surgeons from Mayo Clinic, Stanford Hospital, Hospital for Special Surgery, Boston Children’s Hospital, and other prestigious institutions. Imagen’s technical team consists of machine learning PhDs and engineers with extensive experience doing research and building technology and products at world-class organizations. 

Imagen is a Series C company that was founded in 2015 and has raised $135M from leading venture capitalists, hospitals and health systems, and technology entrepreneurs. Our institutional investors include Google Ventures, Casdin Capital, and Threshold Ventures (formerly DFJ).

We’re looking for a patient-first Software Quality Engineer to work with a cross-functional team to ensure that our cutting-edge software medical devices are built in compliance with our quality system. In this role, you’ll be a key contributor in guiding the building of safe and effective products, a key success metric of Imagen Technologies’ state-of-the-art AI-enabled medical device software. This is a great opportunity for people looking to coach teammates on best technical quality practices and contribute their technical and quality system expertise in a fast-paced, innovative health-tech startup! 

Responsibilities:

• Ensure software is developed in accordance with Imagen's software development lifecycle. You will be a key participant throughout the lifecycle of developing AI medical devices, from establishing requirements and analyzing risk to verification and validation planning, execution, and review.
• Support quality systems activities, including involvement throughout CAPA and nonconformance processes.
• Independently execute supplier evaluations and support non-product software development.
• Collaborate with Cross-Functional Teams to ensure Quality System activities are completed professionally, accurately, and effectively within defined timeframes.
• Create and route quality system procedures, documents, and records within eQMS
• For candidates looking for software development experience, hands-on improvement of internal quality systems software.

Qualifications:

• Mission-driven and passionate about improving healthcare outcomes
• 4+ years experience in quality, 2+ years experience with SaMD or medical devices with a software component
• Experience with CFR 820 Quality Systems Regulations and General Principles of Software Validation applied to end-products. Experience with 62304 is a plus.
• Detail and execution-oriented, with the ability to communicate complex technical ideas effectively, both verbally and in writing
• Bachelor's Degree in Physical Sciences, Life Sciences, Engineering, or Computer Science or have commensurate work experience in a CFR 820 environment

Imagen is committed to the principle of equal employment opportunity for all employees and applicants for employment and prohibits discrimination and harassment of any kind without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.  Imagen will not tolerate discrimination or harassment based on any of these characteristics. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.