Software Test Automation Engineer II

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 in which you can master the following challenges:

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• 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.
  
  

PHYSICAL DEMANDS AND WORKING CONDITIONS:

• The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  
  
  

EXPERIENCE AND REQUIRED SKILLS:

• 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. Bluetooth and Wi-Fi experience is a plus.
• 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.
  
  
  

PREFERRED QUALIFICATIONS:

• 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.
• Experience with cloud-based testing environments.
  
  
  

The rate of pay for this position will depend on the successful candidate’s work location and qualifications, including relevant education, work experience, skills, and competencies.

Hourly Rate: $85,000 - $142,000

Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave and potential for performance-based bonuses depending on company and individual performance.

Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws.

EOE, disability/veterans