An exciting opportunity to be in the early start up stage at OBVIUS Robotics, a well-capitalized medical device company advancing technology in Central Venous Access. This role will oversee the development and continuous improvement of cutting-edge software systems that drive functionality, performance and safety of innovative medical devices.
Essential Job Functions: • Define and design high-level software architecture, ensuring scalability, modularity, and reliability. • Develop the overall software roadmap and strategies to meet the stringent requirements of medical device standards. • In-depth knowledge of real time operating systems (RTOS) principles and operation. • Strong understanding of software-hardware interactions and the ability to optimize and test software for embedded platforms. • Knowledge of wireless communication standards including Bluetooth and Wi-Fi. • Lead efforts to ensure software development complies with IEC 62304, including documentation, risk management, and traceability. • Establish and maintain software lifecycle processes in alignment with regulatory standards. • Implement robust cybersecurity measures to protect sensitive patient data and device integrity. • Stay current with evolving cybersecurity threats and best practices and integrate them into the development process. • Familiarity with IEC 81001-5 and related medical device software development standards. • Provide technical leadership and mentorship to the software development team. • Foster a culture of excellence, compliance, and continuous improvement. • Oversee seamless integration of software components with the various systems, ensuring interoperability and safety. • Collaborate closely with hardware engineers to optimize system performance. • Drive the development of advanced algorithms for robotics control, sensor fusion, and data analysis. • Optimize algorithms for real-time performance, safety, and regulatory compliance. • Enforce software development best practices, including code reviews, testing, and documentation. • Establish rigorous testing protocols to verify software functionality, safety, and compliance. • Serve as a key point of contact for regulatory agencies regarding software-related inquiries. • Support audits, inspections, and related activities for software development compliance including 3rd party testing with NRTLs such as TUV, ETL, and UL. • Perform other related duties incidental to the work described herein.
Qualifications: • Bachelor's, Master's, or PhD degree in Electrical Engineering, Computer Science, Software Engineering, or related field. • 15+ years of experience in software architecture and development for complex systems, preferably in medical device or healthcare industries. • Proficiency in programming languages such as C, C++, Python, or Java. • In-depth knowledge of IEC 62304 and experience in its practical application. • Strong background in FDA software development best practices. • Familiarity with medical device regulatory standards, including FDA regulations and ISO 13485. • Exceptional problem-solving skills in complex, safety-critical environments. • Excellent leadership, communication, and collaboration skills. • Ability to travel as needed to support development, product testing, and customer support.