Test Engineer
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Role details
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Job description
- System Analysis: Understand the system architecture of embedded medical devices (microcontrollers, FPGAs, analog/digital components) and derive test strategies based on functional and safety requirements.
- Test Strategy Development: Define and document test plans for unit, integration, and system-level validation, ensuring traceability to product requirements and compliance with standards like ISO 13485 and IEC 60601.
- Test Framework Architecture: Specify and develop a pytest-based test infrastructure, including software frameworks, automation tools, and hardware interfaces design for reproducible, traceable testing.
- Automation & Execution: Design and implement automated test scripts for functional validation, performance testing, and regression testing.
- Issue Analysis & Reporting: Execute test campaigns, analyze results, report anomalies, and collaborate with design teams to support root cause analysis and resolution.
- Cross-functional Collaboration: Work closely with hardware, firmware, FPGA, and quality teams to ensure test coverage meets regulatory and risk management requirements (e.g., ISO 14971).
Requirements
We are seeking a skilled and detail-oriented Test Engineer to join our team in the development of medical electronic systems that integrate embedded software, FPGAs, and custom electronics. In this role, you will define and implement end-to-end test strategies to ensure the functional safety, reliability, and compliance of our devices with medical regulatory standards., * Master’s degree in Electronics, Computer Engineering, Embedded Systems, or a related field.
- Solid understanding of embedded electronics for regulated systems, including microcontrollers, FPGAs, analog/digital interfaces.
- Hands-on experience with communication protocols: SPI, I2C, UART, Ethernet, etc.
- Proficient in test bench development and automation using tools like Python or LabVIEW
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Experience with measurement instruments (oscilloscopes, logic analyzers) and debugging techniques.
- Comfortable working with version control (Git) and CI tools (e.g., GitLab CI, Jenkins) to integrate tests into development pipelines.
- Familiarity with requirements-based testing, traceability, and formal verification practices in regulated industries.Meticulous, analytical, and structured approach to validation.
- Strong communication skills for cross-functional collaboration.
- Proactive mindset with a focus on quality and patient safety.
Nice to Have
- Experience in the development or validation of medical devices under ISO 13485, IEC 62304, or IEC 60601.
- Knowledge of risk management (ISO 14971) and functional safety (e.g., IEC 61508).
- Familiarity with design controls, V&V planning, and documentation for regulatory submissions.
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