Senior/Intermediate Software & Firmware Engineer

SUMMARY:

We are seeking a Senior/Intermediate Software & Firmware Engineer to lead the development of embedded systems and device software for our next-generation medical devices. In this role, you’ll be a key contributor to product architecture, design, and development from concept through FDA clearance and beyond. You’ll collaborate cross-functionally with systems engineers, hardware teams, and regulatory professionals to ensure our solutions are safe, effective, and user-centric.

POSITION INFO:
Key Responsibilities:

• Taking full ownership of embedded software and firmware development for new medical devices across all phases: concept, specification, prototyping, verification, validation, production, and post-market improvement.
• Design, develop, and test embedded firmware and software for medical devices using C/C++ and/or Python.
• Develop low-level drivers, communication protocols (I2C, SPI, UART, BLE), and RTOS-based systems.
• Participate in risk analysis, code reviews, and verification/validation processes per IEC 62304 and ISO 13485 standards.
• Contribute to architecture decisions and documentation required for regulatory submissions (FDA, CE).
• Mentor junior engineers and provide technical leadership across firmware/software initiatives.
• Developing and reviewing software architecture, algorithms, and power management solutions with a focus on safety, performance, and compliance.
• Working closely with hardware engineers to ensure cohesive product development and support hardware integration goals.
• Interpreting and translating user, clinical, and regulatory requirements into detailed technical specifications and documentation.
• Driving internal and external design reviews, including risk assessments (e.g., FMEA) and compliance planning.
• Maintaining all software and firmware design documentation per ISO 13485, IEC 60601, and FDA requirements.
• Participating in and leading software debugging, lab evaluations, and real-world performance testing, including at clinical sites.

• Bachelor’s degree in Electronic, Electrical, Computer Engineering, or Computer Science.
• Masters Degree in Electronic/Electrical Engineering or Computer Science in medical devices,signal processsing ,embedded system.
• Familiarity with higher-level languages (e.g., JavaScript) and frameworks (e.g., Electron) for cloud integration or user interfaces.
• 3+ years of professional, industry-based experience in embedded software and firmware development.
• Demonstrated experience owning the complete product development lifecycle, from initial design to production release and post-market refinement.
• Strong proficiency in embedded languages such as C/C++, especially on ARM platforms (e.g., Silicon Labs).
• Experience with embedded Linux-based systems.
• Experience in regulated environments—ideally within medical, aerospace, or automotive sectors.
• Strong working knowledge of regulatory design standards (e.g., IEC 60601, ISO 13485, ISO 14971, FDA 21 CFR Part 820).
• Effective collaboration skills within cross-functional, interdisciplinary teams.
• Hands-on experience with lab tools such as oscilloscopes, logic analysers and signal generators for debugging and testing.
• Experience with version control systems (e.g., GIT) and disciplined documentation practices.

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