Software Engineer

Established Search is working with an innovative AI chest imaging company that is redefining diagnostic precision. They are seeking a veteran Medical Device Software Engineer to take ownership of the entire software lifecycle for cutting-edge diagnostic solutions, leading the design of robust software architectures and integrating advanced AI algorithms into clinical practice.

Responsibilities:

• Architect & Innovate: Lead the end-to-end development of medical device software, ensuring strict adherence to IEC 62304 and FDA regulatory frameworks
• AI Integration: Collaborate with data scientists to integrate AI chest imaging models into seamless, high-performance software environments
• Cross-Functional Leadership: Partner with hardware teams, regulatory affairs, and clinical specialists to transform complex requirements into market-ready products
• Rigorous Validation: Design and execute comprehensive verification and validation (V&V) protocols to guarantee patient safety and system efficacy
• Full-Stack Documentation: Maintain meticulous technical documentation, from high-level design specifications to detailed risk management files

Requirements:

• A Bachelor's degree in Computer Science or Software Engineering
• At least 7 years of professional experience
• A deep background in software development within the medical imaging industry
• Expert proficiency in C, C++, or Python
• Hands-on experience with cloud-native architectures and containerized solutions (Docker/K8s)
• Strong familiarity with DICOM standards and medical imaging workflows
• A solid grasp of the regulatory landscape, specifically quality management systems and software lifecycle standards
• Mastery of both Agile and Waterfall methodologies
• A knack for troubleshooting complex, multi-layered system issues