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.
Minimum Requirements:
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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