Principal Software Engineer - Urology

About the Role

Key Responsibilities

• 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 14971 and 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.

Requirements

• 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.
• 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.

Nice to Have

• 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.
• Experience using oscilloscopes, logic analyzers, and other related tools.
• Strong C/C++ skills for programming microcontroller systems.
• 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.

Qualifications

• Educational background in Computer Science, Electrical Engineering, or related fields.
• Experience in software development for medical devices and embedded systems.

Benefits & Perks

• Anticipated compensation ranges from $99,100 to $188,300, commensurate with experience and education.
• Core and optional employee benefits (details at www.bscbenefitsconnect.com).
• Potential variable compensation including annual bonus and long-term incentives.
• Supportive work environment with access to latest tools, training, and career advancement opportunities.