Senior Embedded Software Engineer

About the Role

Key Responsibilities

• Participate in technology evaluations, technical specification development, technical assessments and validation of firmware architectures, embedded software, and system integration aspects of active implantable medical devices.
• Support the firmware specification development, firmware architecture, embedded firmware development, and integration for active implantable medical devices.
• Ensure that firmware development aligns with IEC 62304, FDA, ISO 13485, ISO 14971 and other regulatory standards governing medical device firmware.
• Participate in identifying potential risks, cybersecurity vulnerabilities, and integration challenges in acquired technologies, ensuring firmware meets cybersecurity and safety standards including FDA premarket cybersecurity guidance and IEC 62443.
• Collaborate with cross-functional teams including hardware engineers, systems engineers, risk management, regulatory affairs, and clinical teams to ensure seamless device integration.
• Maintain thorough design documentation, traceability matrices, and SDLC artifacts for regulatory submissions.
• Participate in software and system risk management activities throughout the SDLC.
• Participate in testing strategies (Unit/Integration) and design verification protocols to verify firmware functionality.
• Provide technical inputs on low-power embedded systems, wireless communication (e.g., BLE, NFC, RF telemetry), and real-time operating systems (RTOS).
• Establish and document firmware development lifecycle (SDLC) artifacts and processes to align with internal quality management systems (QMS).
• Perform firmware testing, debugging, and verification efforts using tools such as unit testing frameworks, hardware-in-the-loop (HIL) simulations, and automated test environments.
• Collaborate with regulatory teams on 510(k), PMA, or CE Mark submissions involving firmware-related changes.
• Contribute to the process of transferring the product from development to manufacturing.
• Foster a culture of innovation, continuous improvement, and knowledge sharing within the R&D team.

Requirements

• Bachelor's degree or higher in Computer Science, Computer Engineering, Software Engineering, Electrical Engineering, or related major.
• 4+ years of experience in embedded firmware development.
• 2+ years in implantable or Class III medical devices, wearable devices, or IoT devices.
• Strong C/C++ skills for programming microcontroller systems.
• Expertise in low-power embedded systems, programming for systems with or without RTOS, and microcontroller-based firmware development.
• Experience in firmware risk assessment, cybersecurity, and regulatory compliance for implantable devices.
• Experience using oscilloscopes, logic analyzers, and related tools.
• Strong project management and communication skills.
• Detail-oriented and well organized.
• 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).
• Willingness to work onsite at Irvine, CA.

Nice to Have

• Knowledge of ISO 13485 and FDA QSR.
• Experience with mergers & acquisitions (M&A) due diligence in the medical device sector.
• Hands-on experience with secure bootloaders, cryptographic protocols, and over-the-air firmware updates for implantable devices.
• Expertise in BLE (Bluetooth Low Energy) in embedded systems including peripheral, central, dual roles, pairing, GATT profiles, security, and custom services.
• Low level understanding of BLE software stacks (e.g., from On Semi, Nordic) and experience in optimizing BLE software stack for performance and ultra-low-power consumption constraints.

Qualifications

• Bachelor's degree or higher in relevant engineering or computer science field.
• Experience in embedded firmware development for medical or IoT devices.

Benefits & Perks

• Competitive salary range from $86,600 to $164,500, commensurate with experience.
• Core and optional employee benefits (details at www.bscbenefitsconnect.com).
• Potential variable compensation including annual bonus and long-term incentives.
• Supportive work environment focused on innovation, continuous improvement, and knowledge sharing.
• Opportunity to work in a global company committed to advancing science for life.