Software Testing Engineer

Location: Tel-Aviv

Department: Quality Assurance

Reports to: VP QA/RA

Employment Type: Full-time

About ENvizion Medical

ENvizion Medical is a leading innovator in the medical device field, specializing in electromagnetic enteral feeding placement systems. Our mission is to transform patient care by creating technology that prevents critical errors, ensuring feeding tube placement accuracy, and enhancing safety. As part of a company that values excellence, innovation, and collaboration, you’ll be working alongside a passionate team committed to revolutionizing the healthcare industry.

Job Overview

As a Software Testing Engineer, you will play an integral role in developing life-saving medical technology. Your work will ensure the quality, reliability, and performance of ENvizion Medical’s software systems, including the ENvue enteral feeding platform, used in critical patient care environments. You will work closely with cross-functional teams to ensure compliance with stringent regulatory standards while continuously improving testing processes. This is an exciting opportunity to apply your software testing skills in a highly regulated, mission-driven industry where the accuracy and reliability of software can have life-changing impacts.

Key Responsibilities

• Ensuring compliance to design controls, FDA guidance documents and IEC 62304: Ensure software documentation and testing is developed in compliance with Design Controls, FDA guidance documents associated with software and 62304.
• Test Plan Development: Create and execute comprehensive test plans, including functional, performance, and user scenario testing, ensuring all product features are covered.
• Software Testing: Conduct manual and automated testing on software applications, including embedded systems, to identify defects and ensure that medical-grade performance standards are met.
• Code Reviews and Design Review: Lead and participate in code reviews and design reviews. 
• Automation: Build and maintain automated testing frameworks to increase efficiency, reliability, and scalability of testing processes.
• Bug Tracking: Accurately report bugs, issues, and software defects using tools such as Jira, ensuring efficient communication between development, quality assurance, and regulatory teams. Ensure proper and timely closure of all open issues.  Track and maintain the known bug list. 
• Cross-Functional Collaboration: Work alongside product development, software engineering, regulatory affairs and quality assurance teams to align testing strategies with product goals and regulatory compliance.
• Compliance: Ensure that all testing activities adhere to FDA regulations and medical device standards such as ISO 13485 and IEC 62304. Participate in audits and provide documentation to support regulatory submissions.
• Performance Testing: Conduct tests on the software to ensure it performs efficiently under various clinical conditions and meets the needs of healthcare providers in real-time, critical care settings.
• Regression Testing: Develop, document and execute regression tests to ensure the continuous functionality of the software after updates or patches.
• Documentation: Prepare and maintain all relevant test documentation, including test scripts, results, defect logs, and validation reports, ensuring clear and traceable records for regulatory compliance.
• Continuous Improvement: Actively seek and suggest improvements to testing methodologies, contributing to a culture of innovation and continuous development.

Required Qualifications

• Education: Bachelor’s degree in Computer Science, Software Engineering, or a related field.
• Experience:
  • 3+ years of software testing experience, preferably in a regulated industry such as medical devices, automotive, aerospace, or pharmaceuticals.
  • Proven experience in automated testing tools such as Selenium, Robot Framework, or similar.
  • Knowledge of FDA and ISO 13485 standards, or the ability to quickly learn and apply them.
• Technical Skills:
  • Proficiency in programming or scripting languages like Python, Java, or C# for test automation.
  • Knowledge of IEC 62304 Software Development standard and ISO 14971 Risk Management standard, or the ability to quickly learn and apply.
• Communication:
  • Strong communication skills for clear reporting and collaboration across teams.
• Attention to Detail:
  • Ability to identify subtle defects and inconsistencies in software and coding, with a high level of accuracy.

Preferred Qualifications

• ISTQB or similar certification in software testing.
• Experience in testing medical devices or embedded systems.
• Familiarity with CI/CD pipelines and test management tools such as TestRail.
• Knowledge of Agile or Scrum methodologies and associated tools.

What We Offer

• Make a Real Impact: At ENvizion Medical, your work will directly impact patient care and safety. You’ll have the opportunity to contribute to technologies that make a meaningful difference in healthcare.
• Growth & Development: We’re invested in your professional growth. You’ll have access to continuous learning opportunities, including certifications, training, and workshops to further your career.
• Collaborative Environment: Join a passionate and innovative team that values collaboration, creativity, and problem-solving. We foster an open, supportive environment where your ideas and input are encouraged.
• Work-Life Balance: We understand the importance of balance and we provide a setup that lets you thrive both professionally and personally.
• Cutting-Edge Technology: Be part of a company that’s at the forefront of medical innovation. You’ll work with advanced technologies in a dynamic field, helping to shape the future of enteral feeding systems.