Medical Device Firmware Engineer #9522
📌Irvine, CA, United States 🇺🇸
⏱︎ full-time
🧙♂️ mid-level
on-site
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
As an Embedded Software Engineer, you will be part of the evaluation, and integration of firmware technologies for active implantable medical devices. As a hands-on contributor, you
will support integration activities and firmware development of implantable devices, ensuring compliance with medical device regulations. This role requires expertise in embedded systems, system integration, real-time firmware development, and regulatory-compliant medical device firmware development. You will use your expertise in embedded systems, system integration, real-time firmware development, and regulatory-compliant medical device firmware development.
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 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.
- Create, maintain, or update 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 integration to sustaining engineering.
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Contribute to a culture of innovation, continuous improvement, and knowledge sharing within the R&D team.
- Bachelor’s degree or higher in Computer Science, Computer Engineering, Software Engineering, Electrical Engineering, or related major
- 3+ years of experience in embedded firmware development 1+ years in implantable or Class III medical devices.
- Strong C/C++ skills for programming microcontroller systems.
- Expertise in low-power embedded systems, programming for systems with or without real-time operating systems (RTOS), and 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.
- 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).
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Hands-on experience with oscilloscopes, logic analyzers and other related tools.
- Knowledge of ISO 13485 and FDA QSR.
- Willingness to work onsite at our Irvine, CA site
- 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, custom services.
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Low level understanding of BLE software stacks (e.g. those from On Semi, Nordic) and experience in optimizing BLE software stack for performance constraints and ultra-low- power consumption constraints.
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.
Senior Embedded Software Engineer
@ Embedd 
What we're looking for
At embedd.it, we power hardware-software integration in embedded devices. We turn fragmented semiconductor chip data into configurable digital twins, then deterministically generate code, tests, and documentation – making integration faster, cheaper, and resilient to supply chain shocks.
We’re looking for a true legend – someone with abstract thinking and deep expertise in low-level software development. You’ll build vendor-agnostic tooling for MCU and peripheral integration to solve hardware-software integration once and for all. We work at the intersection of embedded systems, code generation, compilers, and machine learning. It’s your chance to help redefine how low-level development is done.
Responsibilities
- Drive the architecture of the driver structures and system layout
- Define scalable patterns for cross-architectural integration across bare-metal, Zephyr, Linux, and other environments
- Deconstruct complex SoC device trees and translate hardware descriptions into structured internal models for automated reasoning
- Partner with the ML team to shape data and annotation models for AI-driven data-extraction tooling
Qualifications
- 5+ years of experience in embedded systems development, including bare-metal and RTOS-based systems
- Proficiency in C/C++
- Familiarity with firmware configuration, SoC bring-up, and system-level debugging
- Hands-on experience with code generation tools, or low-level compiler/decompiler/emulator technologies
- Strong background in embedded toolchains: compilers, linkers, debuggers, and build systems
- Python or scripting for automation and tooling is a plus
- Experience with functional-safety standards is a plus
Why embedd.it?
- Dynamic, venture-backed team of engineers challenging the status quo 🚀
- Work at the intersection of embedded systems, code generators, compilers, and ML 🤖
- Unusual challenges requiring out-of-the-box abstract thinking 🧠
- Competitive compensation: cash + equity 💰
- Remote work possible 🌍
About Us
embedd.it is a UK-based startup reinventing embedded development. Our platform transforms unstructured semiconductor data into structured digital twins, enabling automatic generation of drivers, tests, and documentation. We're building a single, traceable source of truth to make integration fast, vendor-agnostic, and future-proof.
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Employment
⏱︎ full-time
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Experience
🧙♂️ mid-level
-
Working model
on-site
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Skills
-
Industry
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