Principal Software Engineer

Participate in technology evaluations, technical assessments and validation of software architectures, embedded software, and system integration aspects of acquired implantable medical devices. Support software architecture, development, testing strategies and risk management activities for software applications Evaluate compliance and ensure software/firmware development aligns with IEC 62304, FDA, ISO 13485, ISO 14971and other regulatory standards governing medical devices. Oversee testing strategies (Unit/Integration) and design verification protocols to verify software/firmware functionality post-acquisition. Support software/ firmware testing, debugging, and verification efforts using tools such as unit testing frameworks, hardware-in-the-loop (HIL) simulations, and automated test environments. Identify potential risks, cybersecurity vulnerabilities, and integration challenges in acquired technologies. Ensure acquired software meets medical device cybersecurity and safety standards, including FDA premarket cybersecurity guidance, IEC 62443. Collaborate with cross-functional teams, including hardware engineers, systems engineers, quality, regulatory affairs, manufacturing and PMO to ensure seamless device integration. Establish and document software development lifecycle (SDLC) artifacts and processes to align with internal quality management systems (QMS). Maintain thorough design documentation, traceability matrices, and SDLC artifacts for regulatory submissions. Provide technical inputs on low-power embedded systems, wireless communication (e.g., BLE, NFC, RF telemetry), and real-time operating systems (RTOS). Act as a technical mentor for software engineers, guiding best practices during integration and new product software/firmware development Collaborate with regulatory teams on 510(k), PMA, or CE Mark submissions involving firmware-related changes. Foster a culture of innovation, continuous improvement, and knowledge sharing within the R&D team. B.S or higher in Computer Science, Electrical Engineering, Computer Engineering, Software Engineering or related major. 5+ years of experience in software development . (Master's degree may substitute for one year of experience) 3+ years in embedded or application software for medical devices Sound knowledge of software engineering principles and practices. Knowledge of programming languages such as Swift, Java, Dart, or Objective-C and mobile operating systems and platforms such as iOS and Android. Experience in developing mobile applications in an FDA regulated environment or other regulated industry. Strong C/C++ skills for programming microcontroller systems. Knowledge and use of OOP design principles, API design principles. Knowledge in low-power embedded systems, real-time operating systems (RTOS), and microcontroller-based firmware development. Strong project management and communication skills. Ability to work at our Irvine, CA site Experience with mergers & acquisitions (M&A) due diligence in the medical device sector. Experience in risk assessment, cybersecurity, and regulatory compliance for implantable devices. Knowledge of ISO 13485 and FDA QSR is desired. Experience using oscilloscopes, logic analyzers, and other related tools. Detailed knowledge of BLE stacks and BLE API on mobile platforms Experience in integrating BLE embedded systems with iOS, Android and Windows applications. Knowledge of PC application development in Microsoft Visual Studio (e.g. C#.Net). Hands-on experience with secure bootloaders, cryptographic protocols, and over-the-air firmware updates for implantable devices.