Advantage Technical · 7 hours ago
Firmware Engineer
Irvine, CA
Full-time
Hybrid
Mid, Senior Level
$50/hr - $55/hr
4+ years expAdvantage Technical is seeking a Firmware Engineer to evaluate firmware technologies for active implantable medical devices at Boston Scientific. The role involves ensuring firmware compliance with quality systems, collaborating with cross-functional teams, and participating in the development and testing of firmware architectures for medical devices.
Staffing & Recruiting
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
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 and wireless communication (e.g., BLE, NFC, RF telemetry)
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
Qualification
Required
Bachelor's degree or higher in Computer Science, Computer Engineering, Software Engineering, Electrical Engineering, or related major. Will look at someone with MS degree plus 2+ years of embedded firmware development
4+ years of experience in embedded firmware development
Strong C and C# skills for programming microcontroller systems
Expertise in programming for systems 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. Hybrid position
Preferred
Experience with active implantable medical devices - will move to top
Knowledge of ISO 13485 and FDA QSR
Expertise in low-power embedded systems
Benefits
Medical, dental, and vision coverage
Retirement and savings plans
Paid holidays and time off
Supplemental insurance
Additional wellness or incentive programs
Company
Advantage Technical
Advantage Technical aligns people and companies to create opportunity.
10001+ employees
H1B Sponsorship
Advantage Technical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (1)
2022 (7)
2021 (10)
2020 (48)
Funding
Current Stage
Late StageCompany data provided by crunchbase