Medical Devices - Senior Hardware Design Engineer

Xavant Technology; Pretoria; On-site; ZAR 60 000 - 100 000; Full time

Job summary

An innovative medical device company is seeking a Senior Hardware Design Engineer to lead hardware development for cutting-edge neuromuscular monitoring solutions. This pivotal role involves overseeing the entire lifecycle of hardware products, from concept to commercialization, ensuring compliance with stringent regulatory standards. You'll work closely with cross-functional teams, including embedded software engineers and clinical partners, to create impactful medical technology that enhances patient safety. Join a passionate team dedicated to improving global health through advanced medical devices and make a real difference in the industry.

Benefits

Dynamic work environment

Collaboration with clinicians

Opportunities for innovation

Impact on global health

Qualifications

• 5+ years of experience in electronic hardware design required.
• Strong knowledge of regulatory standards like IEC 60601 and ISO 13485.
• Hands-on experience with lab tools and circuit design.

Responsibilities

• Take ownership of hardware development for medical devices.
• Collaborate with external PCB design houses for layout.
• Drive internal and external design reviews and compliance planning.

Skills

Analog and digital circuit design

Power supply systems specification

Collaboration skills

Regulatory design standards knowledge

Creative problem-solving

Education

Bachelor's degree in Electronic or Electrical Engineering

Master's degree in Electronic/Electrical Engineering

Tools

Oscilloscopes

Logic analyzers

Signal generators

Version control systems (GIT)

Job description

Location: Pretoria, South Africa (On-site)

Experience Level: Senior (5+ years, industry only)

Industry: Medical Devices – Neuromuscular Monitoring

Position Type: Full-time

About Xavant Technology

Xavant Technology is a pioneering South African medical device company based in Pretoria, dedicated to advancing patient safety through innovative neuromuscular monitoring solutions. Our flagship product, the Stimpod NMS450X+, combines Acceleromyography (AMG) and Electromyography (EMG) in a single portable device—helping anesthesiologists worldwide make better, safer clinical decisions.

About the Role

We’re looking for a technically strong, experienced, and mission-driven Senior Hardware Design Engineer to join our core R&D team. This leadership-oriented role involves full responsibility for hardware architecture and design across the entire lifecycle of our medical 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 emphasizes 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 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.

What We Offer

• A dynamic and innovative work environment with a direct impact on global health.
• Opportunities to collaborate closely with clinicians and see your work in action.
• A skilled, passionate team with deep medical device expertise.
• The chance to contribute meaningfully from concept to commercialization.