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As a medical device Software Test Automation Engineer II in Fresenius Medical Care's Home business unit, you will be able to make a valuable contribution every day to improving the quality of life of our patients of home dialysis therapies with the development of peritoneal dialysis devices. You can expect a dynamic, global, yet familiar environment.
Job Responsibility:
Design, develop, and maintain automated test frameworks and test scripts for embedded and/or application software
Collaborate with software engineers, systems engineers, and quality teams to define verification strategies
Execute software test protocols, especially software integration tests and software system test protocols for embedded software
Integrate automated testing into CI/CD pipelines
Support software verification and validation activities in accordance with FDA 21 CFR Part 820, ISO 13485, IEC 62304, ISO 14971 (risk management)
Participate in risk analysis and ensure appropriate test coverage for risk controls
Participate in software verification plan and protocol reviews and other related design reviews
Investigate, document, and track software defects using defect tracking tools
Contribute to continuous improvement of QA processes and automation strategies
Create, identify, validate, and use test tools that facilitate data gathering and test method execution
Conduct and report on Engineering Tests
Support internal and external audits as needed
Requirements:
Bachelor’s degree in Computer Engineering, Software Engineering, Electrical Engineering, or related field
3+ years of experience in software testing, with at least 2 years in automation
Experience in medical device, life sciences, or other regulated industries
Proficiency in Python, Bash, and C/C++/C# programming languages
Familiarity with messaging-based protocols (e.g., MQTT, ZeroMQ)
Experience with embedded Linux and device drivers
Experience with automation tools and frameworks (e.g., Selenium, pytest, Robot Framework, NUnit, Rest API, custom, or similar)
Experience in TCP/IP and other method of communications
Knowledge of GUI development and testing with Qt
Understanding of software development life cycle (SDLC) in regulated environments
Experience with version control systems (e.g., Git, Azure DevOps)
Knowledge of defect tracking and test management tools
Familiarity with Agile software development approaches, preferably Scrum
Strong documentation skills and attention to detail
Nice to have:
Bluetooth and Wi-Fi experience
Experience with embedded systems testing
Familiarity with hardware/software integration testing
Experience with automated test equipment and test harness development
Knowledge of cybersecurity considerations for medical devices