Manager, Software Testing

WHO ARE WE?

Endotronix is a medical device company that aims to transform the treatment of heart failure, a chronic, progressive condition in which the heart is unable to pump enough blood to support the body.  Our Cordella Heart Failure System (CHFS) includes proactive management tools for best practice care and detection of worsening heart failure.   These easy-to-use tools improve patient quality of life and help to reduce hospital admissions thereby reducing health care costs.  With our recent PMA approval from the FDA and acquisition by Edwards Lifesciences, we are growing our team – it’s a great time to join Endotronix!

WHAT YOU’LL DO

As the Manager of Software Testing, you will be responsible for overseeing the planning, execution, and delivery of software testing efforts within the organization. You will ensure high-quality software products are delivered to customers by leading a team of skilled testers, optimizing processes, and implementing best practices in quality assurance and testing.  The role is also responsible for ensuring compliance with regulatory standards, patient safety, and the delivery of reliable and high-quality medical software.  This is a hybrid position based in Naperville, Illinois.   Responsibilities include:

Leadership:

• Lead and manage a team of software test engineers.
• Conduct regular performance reviews and foster a culture of continuous improvement and accountability. 

Regulatory Compliance:

• Ensure all software testing activities adhere to relevant regulatory standards, including ISO 13485, IEC 62304, FDA Guidelines and other applicable guidelines.
• Maintain thorough documentation for audits and regulatory inspections. 

Test Strategy and Planning:

• Develop and implement comprehensive test plans, ensuring thorough coverage for functional, performance, usability, and other testing.
• Oversee risk-based testing approaches to prioritize critical functionality and safety features.
• Plan and execute validation and verification activities throughout the software development lifecycle. 

Quality Assurance Processes:

• Identify process inefficiencies and recommend improvements to enhance testing effectiveness.
• Ensure traceability between requirements, tests, and defects to support compliance and quality goals. 

Collaboration and Communication:

• Work closely with R&D, Regulatory, Quality, and clinical teams to understand requirements and potential risks.
• Participate in design reviews, risk assessments, and usability evaluations. 

Tool and Technology Management:

• Evaluate, select, and implement testing tools and frameworks suitable for medical device hardware and software.
• Advocate for automation where appropriate, ensuring balance with manual testing for critical systems.
• Stay current on emerging testing technologies and techniques in the medical device industry. 

Reporting:

• Analyze testing metrics and provide detailed reports to stakeholders.
• Contribute to root cause analysis to prevent recurring defects.

WHAT YOU BRING TO THE TABLE

Experience:

• 7+ years of experience in software testing, with at least 2-3 years in a leadership or managerial role.
• Experience in testing software for medical devices or other regulated industries. 
• Proven track record of managing testing efforts for complex software eco systems.

Skills:

• Strong knowledge of QA methodologies, tools, and processes.
• Strong knowledge of regulatory standards such as IEC 62304 and FDA guidelines
• Hands-on experience with automation testing tools (e.g., Selenium, Appium, JUnit).
• Deep understanding of Agile, DevOps, and CI/CD practices.
• Excellent leadership, communication skills with attention to detail.
• Strong analytical and critical-thinking skills.
• Commitment to patient safety and product quality.
• Adaptability to evolving regulatory requirements.

Technical Proficiency:

• Experience in testing web, mobile, embedded, PC-based and cloud-based applications.

EDUCATION 

• Bachelor’s degree in Computer Science, Information Technology, or a related field.

WHO YOU ARE

• Relentlessly focused on data and hypothesis driven decision making to create the best experiences for ETX patients and customers
• Someone with a bias for action and quick iteration as opposed to perfection
• A quick learner, who is able to work independently, multitask, and drive your own projects
• An effective communicator and collaborator who can synthesize insights from multiple stakeholders across business functions to deliver purpose-built insights, models and tools that provide easily interpretable and actionable results
• A team player who can inspire teams to deliver together, embodying the idea that the whole is greater than the sum of the parts
• Passionate about digital healthcare and leveraging Data to deliver innovative solutions at scale 

WHAT WE’RE LIKE

• Willing to have the “direct and honest conversation”. Not afraid to confront the facts (or be confronted) and develop a plan to move forward. 
• Competitive spirit and drive to win. Strong sense of initiative, internal motivation, and an unrelenting focus on results. 
• Openness to feedback and coaching with a strong orientation towards continual learning and improvement. Ability to solicit, accept and provide direct feedback without defensiveness. 
• Capacity to function in a highly complex company with ease and fluidity, while driving and influencing results. 
• Entrepreneurial, flexible, yet results focused. 
• High degree of intellectual curiosity, honesty, and capability. 
• Low ego and humble in spirit in spite of your track record of outstanding performance.  

LIFE AT ENDOTRONIX

• Our shared company values create a foundation of trust and collaboration.  United in a common purpose, we excel at the task at hand to provide best-in-class medical technology and customer service to our patients and clinicians.  And along the way we make sure to have a little fun, continue to grow and celebrate our successes.
• We provide a competitive compensation package, comprehensive benefits, and an environment that will help you to thrive and succeed in your career.
• Endotronix is an equal opportunity employer, and we are committed to providing equal employment opportunities to all persons without regard to race, creed, color, religion, national origin, gender, marital status, citizenship status, age, veteran status, or disability.  We are passionately committed to building a diverse organization where all perspectives and cultures are celebrated.