onsite
Systems Test Engineer - Elucent Medical
QA Engineer
Systems Test Engineer responsible for designing, implementing, and executing system‑level verification and validation tests for surgical navigation devices, using Python, C++, LabVIEW and automated test frameworks while ensuring compliance with FDA standards.
About the role
Key Responsibilities
- Develop, maintain, and execute system‑level verification and validation test plans for surgical navigation hardware and software.
- Create automated test scripts and frameworks using Python, C++, and LabVIEW to improve test efficiency and repeatability.
- Collaborate with hardware, firmware, and software teams to define test requirements, troubleshoot failures, and drive root‑cause analysis.
- Document test results, generate detailed reports, and ensure traceability to design specifications and regulatory requirements.
- Support FDA and ISO compliance activities by providing evidence of testing, risk assessments, and validation documentation.
Requirements
- Bachelor’s degree in Electrical Engineering, Computer Science, Biomedical Engineering, or related field.
- 3+ years of experience in system‑level testing of medical devices or complex electromechanical systems.
- Proficiency in Python, C++, and LabVIEW for test development and automation.
- Strong understanding of FDA 21 CFR Part 820, ISO 13485, and risk management processes.
- Excellent problem‑solving, communication, and documentation skills.
Skills
pythonctest automation