Sustaining Engineer II

Endotronix, Inc • Naperville, IL, US • 1w ago

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 the announcement that we are joining Edwards Lifesciences, we are growing our team – it’s a great time to join Endotronix!

WHAT YOU’LL DO

We are seeking a motivated and detail-oriented Sustaining Engineer to join our fast-growing and dynamic team. This position is ideal for someone with 3-5 years of relevant experience who is passionate about ensuring the highest quality and performance standards for our medical devices. The Sustaining Engineer will play a crucial role in troubleshooting field issues, working closely with manufacturing teams to implement design and process improvements, and maintaining the overall performance and quality of our devices.

Troubleshooting: Investigate and resolve device field issues by analyzing product performance data, customer feedback, and failure reports. Provide timely and effective solutions to minimize device downtime and customer impact.
Design and Process Improvement: Collaborate with cross-functional teams, including R&D and manufacturing, to identify and implement design changes and process improvements that enhance device reliability, performance, and manufacturability.
Device Performance Monitoring: Continuously monitor and assess device performance and quality metrics. Develop and execute plans to address any deviations from established standards and ensure sustained high performance.
Documentation and Compliance: Maintain accurate and comprehensive documentation of engineering changes, troubleshooting activities, and quality control measures. Ensure all activities comply with regulatory requirements and company standards. Collaborate with quality and regulatory to address regulatory requests
Cross-Functional Collaboration: Work closely with manufacturing, quality assurance, and regulatory teams to support product lifecycle management and ensure seamless integration of engineering solutions.

WHAT YOU BRING TO THE TABLE

3-5 years of experience in engineering, preferably within the medical device industry.
Strong problem-solving skills with the ability to analyze complex technical issues and develop practical solutions.
Familiarity with medical device regulations and quality standards (e.g., FDA, ISO) and CAPA process.
Proficiency in engineering software and tools related to design and data analysis.
Experience with design for manufacturability and product lifecycle management.
Knowledge of statistical analysis and quality control methodologies.
Hands-on experience with medical device testing and validation.
Excellent communication skills, both written and verbal, with the ability to work effectively in a team-oriented environment.
Detail-oriented with a strong commitment to documentation and maintaining high quality and performance standards.

EDUCATION

Bachelor’s degree in mechanical engineer, biomedical engineering, electrical engineering 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 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.