Senior / Intermediate Software & Firmware Engineer

Oneconnect; Gauteng; On-site; ZAR 750,000 - 1,200,000; Full time

Job summary

A leading company in medical devices is seeking a Senior / Intermediate Software & Firmware Engineer to drive embedded systems and device software development. This role requires collaboration with cross-functional teams to ensure product safety and effectiveness, guiding projects from concept to FDA clearance with a focus on compliance and user-centric design.

Qualifications

• 3+ years of professional experience in embedded software and firmware development.
• Experience in regulated environments like medical or aerospace sectors.
• Strong working knowledge of regulatory design standards (e.g., IEC, ISO, FDA 21 CFR Part).

Responsibilities

• Lead embedded software and firmware development for medical devices.
• Develop low-level drivers, communication protocols and RTOS-based systems.
• Mentor junior engineers and provide technical leadership.

Skills

C / C++

Python

Embedded Linux

Risk analysis

Compliance

Collaboration

Education

Bachelor's degree in Electronic, Electrical, Computer Engineering, or Computer Science

Master's Degree in Electronic / Electrical Engineering or Computer Science

Tools

GIT

Oscilloscopes

Logic analyzers

Signal generators

Job description

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.

Key Responsibilities :

1. 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.
2. Design, develop, and test embedded firmware and software for medical devices using C / C++ and / or Python.
3. Develop low-level drivers, communication protocols (I2C, SPI, UART, BLE), and RTOS-based systems.
4. Participate in risk analysis, code reviews, and verification / validation processes per IEC and ISO standards.
5. Contribute to architecture decisions and documentation required for regulatory submissions (FDA, CE).
6. Mentor junior engineers and provide technical leadership across firmware / software initiatives.
7. Developing and reviewing software architecture, algorithms, and power management solutions with a focus on safety, performance, and compliance.
8. Work closely with hardware engineers to ensure cohesive product development and support hardware integration goals.
9. Interpret and translate user, clinical, and regulatory requirements into detailed technical specifications and documentation.
10. Drive internal and external design reviews, including risk assessments (e.g., FMEA) and compliance planning.
11. Maintain all software and firmware design documentation per ISO, IEC, and FDA requirements.
12. Participate in and lead 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.
• Master's Degree in Electronic / Electrical Engineering or Computer Science in medical devices, signal processing, embedded systems.
• 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, ISO, FDA 21 CFR Part).
• Effective collaboration skills within cross-functional, interdisciplinary teams.
• Hands-on experience with lab tools such as oscilloscopes, logic analyzers, and signal generators for debugging and testing.
• Experience with version control systems (e.g., GIT) and disciplined documentation practices.