Entegee ยท 4 hours ago
Firmware Engineer
Irvine, CA
Contract
Onsite
Mid Level
$60/hr - $65/hr
4+ years expEntegee is a company seeking a Firmware Engineer to work on active implantable medical devices. The role involves firmware development, compliance with regulatory standards, and collaboration with cross-functional teams to ensure device integration and quality management.
Information TechnologyStaffing Agency
Hiring Manager
Kyle Tavares
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
4+ years of experience in embedded firmware development
Strong C and 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 (eg. C#.Net)
Hands-on experience with oscilloscopes, logic analyzers and other related tools
Benefits
Medical
Dental
Vision
Term life insurance
Short-term disability insurance
Additional voluntary benefits
Commuter benefits
401K plan
Paid Sick Leave
Holiday pay
Company
Entegee
Entegee is a staffing and recruiting company providing contract engineers and technical specialists.
201-500 employees
H1B Sponsorship
Entegee 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 (5)
2024 (2)
2023 (1)
2022 (4)
2021 (8)
2020 (5)
Funding
Current Stage
Growth StageLeadership Team
Bob Bolster
Chief Operating Officer
Company data provided by crunchbase