Jobs at Gentuity, LLC

The Senior Software Engineer will contribute to software architecture, develop imaging application software, create algorithms, and manage technical teams. Responsibilities include software documentation and compliance.

The Principal Software Engineer will develop imaging application software, create architecture, refine software processes, and manage technical teams, focusing on signal processing and software documentation.

Manage and maintain the medical device Quality Management System to meet FDA, ISO, and regional requirements. Oversee document control, CAPA, complaints, supplier management, audits, training, quality metrics, management reviews, and lead regulatory audits. Coach direct reports, drive QMS improvements, and manage related projects.

Support creation and management of labeled medical image datasets for AI algorithms. Collaborate with software, ML, systems engineers and clinical partners to develop data used for automated cardiovascular image analysis. Work on-site in Sudbury, MA.

Develop and manage technical specifications for medical imaging hardware. Conduct compliance testing, support existing products, and lead cross-functional teams.

The role involves developing and leading test strategies for medical device verification, managing testing processes, ensuring compliance with regulatory standards, and overseeing lab operations and team mentoring.