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Senior Firmware Engineer (Med Device) #7729
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ECI 1 day ago Be among the first 25 applicants About ECI
ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry. About the Role
We are seeking a senior‑level engineer to help drive the evaluation of firmware technologies for active implantable medical devices. In this role, you will work with medical device firmware from a recently acquired company to bring the firmware to compliance with our clients quality systems. The ideal candidate will bring strong technical expertise in C or C# development, along with a solid understanding of medical device embedded systems, system integration, and DevOps. This individual should be able to work independently and proactively, demonstrating ownership, problem‑solving, and collaboration skills to ensure a smooth and efficient transition across multiple applications and cross‑functional teams. What You’ll Do
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. 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. 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. What You Will Bring
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 Qualifications
Experience with active implantable medical devices. Knowledge of ISO 13485 and FDA QSR. Expertise in low‑power embedded systems. All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment‑based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.
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Senior Firmware Engineer (Med Device) #7729
role at
ECI 1 day ago Be among the first 25 applicants About ECI
ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry. About the Role
We are seeking a senior‑level engineer to help drive the evaluation of firmware technologies for active implantable medical devices. In this role, you will work with medical device firmware from a recently acquired company to bring the firmware to compliance with our clients quality systems. The ideal candidate will bring strong technical expertise in C or C# development, along with a solid understanding of medical device embedded systems, system integration, and DevOps. This individual should be able to work independently and proactively, demonstrating ownership, problem‑solving, and collaboration skills to ensure a smooth and efficient transition across multiple applications and cross‑functional teams. What You’ll Do
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. 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. 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. What You Will Bring
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 Qualifications
Experience with active implantable medical devices. Knowledge of ISO 13485 and FDA QSR. Expertise in low‑power embedded systems. All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment‑based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.
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