| A vacancy is available for a technically strong and experienced Senior Hardware Engineer to join our client’s R&D team in Pretoria.
This leadership-oriented role involves full responsibility for hardware architecture and design across the entire lifecycle of the company’s Biomedical products—from concept through to commercial production and post-launch improvements.
You’ll guide hardware development for robust, high-performance, and compliant electronics in FDA-approved technologies. While embedded software involvement may be required in support of co-design efforts, this role emphasises hands-on hardware leadership and strategic oversight, including advising external PCB design houses on layout and production constraints.
This is a high-impact position offering the opportunity to directly shape the safety and functionality of globally used medical technology.
Key Responsibilities
- Take full ownership of hardware development for new medical devices across all phases: concept, specification, prototyping, verification, validation, production, and post-market improvement.
- Develop and review system architecture, analogue/digital circuitry, and power designs with a focus on safety, performance, and compliance.
- Advise and collaborate with external PCB layout contractors/design houses, ensuring design intent is met and best practices are followed.
- Interpret and translate user, clinical, and regulatory requirements into detailed technical specifications and documentation.
- Drive internal and external design reviews, including risk assessments (e.g., FMEA) and compliance planning.
- Work closely with embedded software engineers, regulatory staff, clinical partners, and manufacturing to ensure cohesive product development.
- Maintain all hardware design documentation per ISO 13485, IEC 60601, and FDA requirements
- Participate in and lead hardware debugging, lab evaluations, and real-world performance testing, including at clinical sites.
- Support embedded software development as needed, especially in alignment with hardware integration goals.
Minimum Requirements:
- Bachelor’s degree (or higher) in Electronic or Electrical Engineering from an accredited institution.
- 5+ years of professional, industry-based experience in electronic hardware design. Undergraduate years are not accepted as experience for this role
- Demonstrated experience owning the complete hardware product development lifecycle, from initial design to production release and post-market refinement.
- Proven capability in advising and directing external PCB layout/design service providers.
- 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.
- Familiarity with DFM/DFA, production scalability, and design for compliance.
Core Technical Skills:
- Analog and digital circuit design, simulation, and analysis.
- Specification and verification of power supply systems, signal conditioning, and communication interfaces.
- Hands-on experience with lab tools such as oscilloscopes, logic analyzers, signal generators, and power supplies.
- Understanding of hardware interfaces: UART, SPI, I2C, USB, Bluetooth.
- Experience in managing EMC/ESD considerations, and designing for medical-grade safety and performance.
- Version control systems (e.g., GIT) and disciplined documentation practices.
- Familiarity with firmware co-design in Embedded C/C++, especially on ARM platforms (e.g Silicon Labs)
- Bonus: experience with embedded Linux-based systems.
Additional Experience (Bonus):
- Master’s degree in Electronic/Electrical Engineering with a focus on biomedical engineering / medical devices, signal processing, or embedded systems.
- Experience optimizing products for manufacturability and cost-efficiency.
- Exposure to production environments and supply chain collaboration.
- Clinical trial or field-testing experience for safety-critical devices.
- Creative problem-solving under real-world constraints, including troubleshooting of field issues.
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