Quality Engineer II - Failure Analysis

Endotronix

Endotronix

Quality Assurance
Lisle, IL, USA
Posted on Thursday, June 27, 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


You will be responsible for supporting various elements of the Quality System such as Complaint Investigations, Non-Conformance Investigations, and general failure analysis.

  • Perform complex failure analysis of devices/components returned with alleged malfunctions or associated with internal nonconformances.
  • Acquire, analyze, and interpret information from data logs and various applications as part of root cause analysis.
  • Utilize failure analysis laboratory equipment such as: optical digital microscopes, probes, custom electrical test software, data log applications, and other test equipment and fixtures in support of failure analysis.
  • Maintain and calibrate specialized lab equipment for accurate analysis.
  • Participate and/or conduct validation or qualifications tests of new or existing failure analysis equipment in accordance with internal procedures.
  • Collaborate with engineering, product development, complaint management, supplier quality and manufacturing functions to ensure returned product investigations are fully address reported events.
  • Develop and implement methods and procedures to assist in product analysis investigations.
  • Determine potential interaction between reported event and all Endotronix system components.
  • Generate comprehensive failure investigation reports to support findings, root cause, regulatory requirements, and obtain the necessary approvals.
  • Create and develop engineering projects for improvements of analysis/investigation process, methodologies, and procedures.
  • Provide direction for failure analysis technicians to ensure that field returns are evaluated appropriately to deliver clear investigation results and potential root causes for identified failures.
  • Initiate discussions with management and QA when new failure mode(s) is(are) identified during failure analysis.
  • Participate in Corrective Action/Preventive Action (CAPA) process as a CAPA owner or in a supporting role that includes the investigation of failures.
  • Provide frequent verbal and written updates of work-in-progress for various meetings.

WHAT YOU BRING TO THE TABLE

  • 2+ years’ experience in a quality engineering role and/or an advanced degree
  • Experience with quality principles and tools
  • Skills in root cause analysis and determination of appropriate corrective action
  • Working knowledge of ISO 13485 requirements
  • Ability to work in a team environment, manage multi-tasking, and discipline in completing tasks on schedule
  • Technical writing skills, experience creating SOPs/WIs in a Quality Management System
  • Experience in the medical device industry, preferably with electromechanical devices and medical device software desired

EDUCATION

  • BS in Engineering (preferably Electrical or Biomedical)

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.