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, acquisition by Edwards Lifesciences, and becoming a commercial company in the U.S., we are preparing to grow our team – it’s a great time to join Endotronix!

WHAT YOU’LL DO

As a Systems Engineer, this individual will be a member of the Research & Development team, responsible for new product design and development, risk management, and product performance improvements for the hardware components of the Cordella platform. This is a collaborative position in which the Systems Engineer will work closely with other hardware and software engineers, quality, regulatory, manufacturing, and other individuals throughout the company. This is a full-time, onsite position in Naperville, IL. Your responsibilities will include:

• Product Development Activities
  1. Verification and validation testing, including test method development, protocol writing, test execution, data analysis, and report writing
  2. Design change impact assessments
  3. Risk management activities, including Hazard Analysis, Design FMEAs, and Use FMEAs
  4. Standards compliance
  5. User research and usability assessments/validation
  6. Build and maintain the design history file
• Troubleshooting and Problem Solving
  1. Troubleshoot device problems and test failures
  2. Develop strategies and solutions to navigate the design and development process
• Act as technical resource for field support

WHAT YOU BRING TO THE TABLE

• 3-5 years medical device engineering experience
• Prior experience performing testing to support V&V and risk management activities for medical device development
• Prior experience working within Design Controls and DHF ownership
• Prior experience processing, parsing, and analyzing data, including script development for automation and statistical analysis methods using Excel and Minitab
• Demonstrated ability to work independently with minimal supervision
• Excellent oral and written communication skills, particularly in technical writing, documentation, and presentations
• Demonstrated organizational, interpersonal, and critical thinking skills
• Experience with medical devices and FDA quality practices and standards, including ISO 13485

EDUCATION

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 including unlimited PTO, 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.