Software Testing Engineer

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:

o 3+ years of software testing experience, preferably in a regulated

industry such as medical devices, automotive, aerospace, or

pharmaceuticals.

o Proven experience in automated testing tools such as Selenium, Robot

Framework, or similar.

o Knowledge of FDA and ISO 13485 standards, or the ability to quickly

learn and apply them.

• Technical Skills:

o Proficiency in programming or scripting languages like Python, Java, or

C# for test automation.

o Knowledge of IEC 62304 Software Development standard and ISO

14971 Risk Management standard, or the ability to quickly learn and

apply.

• Communication:

o Strong communication skills for clear reporting and collaboration

across teams.

• Attention to Detail:

o 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.