Quality Engineer

Endotronix

Endotronix

Quality Assurance
Naperville, IL, USA
Posted on Tuesday, June 4, 2024

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.

WHAT YOU’LL DO

As a member of the Quality Team, you will review and monitor risk analyses, design verification/validation protocols and reports. Ensure test methodologies are technically sound and sufficient given the level of risk assessed. Support regulatory requirements by participating in design reviews. Encourage continuous improvement in all documented procedures to help streamline production. Your responsibilities will include:

  • Develop a thorough understanding of the entire product lifecycle for Endotronix product.
  • Provide quality engineering input to establishment of product specifications, quality plans, and manufacturing procedures which consider risk management.
  • Review and approval of design verification and validation protocols and reports to ensure that test article selection, sampling rationales and test methodologies are technically sound and sufficient given level of risk and internal/external requirements.
  • Review risk analyses and design and usability FMEAs for adherence to requirements.
  • Participate in design reviews to ensure customer and regulatory requirements have been properly translated into design inputs which are complete, unambiguous and do not conflict.
  • Encourage continuous improvement in design control activities and proactive utilization of quality tools with design team.
  • Support design for manufacturing in the design phase through design transfer to manufacturing, both internally and externally.
  • Support manufacturing process optimization to encourage reproducible quality
  • outcomes.
  • Assist with management and monitoring of process control metrics in manufacturing environment.
  • Develop sampling plans for quality assurance based on product risk and supplier performance.
  • Perform root cause analysis of field, incoming, and manufacturing issues and implement corrective actions.
  • Support suppliers and internal investigations on quality related issues and returned material analyses.
  • Model a culture of quality within the company and guide employees in best quality practices.

WHAT YOU BRING TO THE TABLE

  • 2+ years' experience in quality engineering role
  • Experience with quality principles and tools
  • Capability in application of statistical techniques and sampling plans
  • Skills in root cause analysis and determination of appropriate corrective action
  • Working knowledge of IS013485 and IS014971 requirements
  • Strong organizational skills and ability to work independently and part of a team

EDUCATION

  • Bachelor of Science in Engineering

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.