ECI ยท 1 week ago
Senior Firmware Engineer (Med Device) #7729
Irvine, CA
Full-time
Hybrid
Mid, Senior Level
4+ years expECI is a global leader in professional consulting services for the life sciences industry, and they are seeking a Senior Firmware Engineer to evaluate firmware technologies for active implantable medical devices. The role involves ensuring compliance with quality systems, collaborating with cross-functional teams, and managing firmware development aligned with regulatory standards.
BiotechnologyConsultingLife ScienceProject Management
No H1B
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 14971and other regulatory standards governing medical device firmware
Participate in Identifying potential risks, cybersecurity vulnerabilities, and integration challenges in acquired technologies. Ensure acquired firmware meets medical device cybersecurity and safety standards, including FDA premarket cybersecurity guidance, 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 software development lifecycle (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
Contributes 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
Qualification
Required
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
Strong C/C# skills for programming microcontroller systems
Expertise in programming for systems with or without real-time operating systems (RTOS) and in microcontroller-based firmware development
Experience in firmware risk assessment, cybersecurity, and regulatory compliance for implantable devices
Experience using oscilloscopes, logic analyzers, and other related tools
Strong project management and communication skills
Detail-oriented and well organized
Knowledge of PC application development in Microsoft Visual Studio (e.g. C#.Net)
Hands-on experience with oscilloscopes, logic analyzers and other related tools
Willingness to either work onsite at our Irvine, CA site or travel to this location
Preferred
Experience with active implantable medical devices
Knowledge of ISO 13485 and FDA QSR
Expertise in low-power embedded systems
Company
ECI
ECI (Enhanced Compliance Inc.) stands as a beacon of excellence in the life sciences consulting arena.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Michael Boyer
Chief Financial Officer
Shital Patel
Chief Operating Officer
Company data provided by crunchbase