Role Overview
An established engineering organization is looking for a skilled Embedded Verification and Validation Engineer with a minimum of three years of experience in testing software or firmware for medical devices. This position plays a key role in ensuring embedded systems meet strict regulatory and safety requirements through rigorous testing and validation processes.
Key Responsibilities
- Create and maintain test plans, protocols, and validation reports for embedded system components.
- Conduct unit, integration, system-level, and regression testing across firmware modules.
- Perform both manual and automated testing procedures on embedded software used in medical devices.
- Write and maintain automated test scripts using Python, C, C++, or compatible testing frameworks.
- Set up and manage test environments, including hardware test benches and simulation platforms.
- Integrate testing workflows into CI/CD pipelines to support continuous validation.
- Ensure all development and testing activities comply with FDA regulations, IEC 62304, ISO 13485, and ISO 14971 standards.
- Develop traceability matrices, document validation outcomes, and maintain detailed defect records.
- Collaborate with embedded software developers, system architects, hardware engineers, and quality assurance teams.
- Support design reviews, risk analysis sessions, and root cause investigations.
- Use tools such as JIRA, Polarion, or comparable ALM systems to log, track, and resolve defects.
- Conduct failure analysis and support debugging efforts alongside development staff.
Required Qualifications
- Minimum of three years in embedded software verification and validation, preferably within the medical technology sector.
- Proven experience testing embedded systems in regulated environments.
- Familiarity with medical device standards including ISO 13485, IEC 62304, and risk management principles.
- Solid understanding of C and C++ programming languages.
- Experience writing scripts in Python or other languages for test automation.
- Hands-on knowledge of hardware communication interfaces such as UART, SPI, I2C, CAN, and USB.
- Proficiency with test and debugging equipment including oscilloscopes and logic analyzers.
- Experience maintaining requirements traceability across the development lifecycle.
Preferred Qualifications
- Background working in regulated environments focused on medical devices.
- Understanding of risk management practices and safety-critical software development.
- Experience with hardware-in-the-loop (HIL) testing methodologies.
- Familiarity with clinical workflows or systems involving medical imaging technologies.
Technical Environment
Python, C, C++, JIRA, TestRail, Polarion, Git, Jenkins, GitLab, UART, SPI, I2C, CAN, USB, oscilloscope, logic analyzer
