Principal Software Architect

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.

Location:                     South Florida, East coast