Imagen is extending the frontiers of medicine and artificial intelligence (AI) to improve human well-being. In the short term, we are building state-of-the-art AI software to reduce diagnostic errors in radiology and improve patient outcomes. Over the long term, we are transforming early disease identification and management through our interdisciplinary research at the intersection of medicine and AI.

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 comprised of radiologists and surgeons from Mayo Clinic, Stanford Hospital, Hospital for Special Surgery, Boston Children’s Hospital, and others. Imagen’s technical team is comprised of machine learning PhDs and engineers with extensive experience doing research and building technology and products at world-class organizations.

We were founded in 2016 and have raised $60M from leading venture capitalists, hospitals and health systems, and technology entrepreneurs. Our institutional investors include DFJ and GV. 

We’re looking for a Quality Manager to ensure compliance to 21 CFR Part 820 through the implementation and maintenance of our Quality Management System (QMS). As a Quality Manager, you will be a leader in the development of new procedures, creating novel approaches to V&V in the world of machine learning, and adapting agile software engineering practices to fit the regulated world of Medical Devices. Our ideal candidate is someone with direct experience in oversight and strategy of quality assurance activities to ensure compliance with applicable regulatory requirements. 

Responsibilities:

• Provide proactive quality support for process improvement and drive the development and maintenance of documentation to maintain compliance with FDA regulations and ISO 13485
• Collaborate with the R&D organization to help facilitate the successful execution of design control deliverables including participation in design reviews, reviewing & approving design verification & validation activities, and creating protocols & requirements for IQ / OQ / PQ.
• Foster a quality culture focused on meeting high quality, ethical and compliance standards
• Build, execute and monitor an effective internal audit program
• Manage post-market lifecycle processes for our products, including complaint handling

Qualifications:

• Mission-driven and passionate about improving healthcare outcomes
• 4+ years of experience in Quality and FDA / ISO 13485 compliant software development
• Strong familiarity with the software engineering lifecycle and QA methodology
• Detail and execution oriented, with the ability to communicate complex ideas effectively, both verbally and in writing

This role is based in New York, NY.