Manufacturing Process Engineer

6 days ago


Naperville, Illinois, United States Endotronix, Inc Full time
Job Overview
Endotronix, Inc is a leading medical device company focused on transforming heart failure treatment. We are seeking a talented Manufacturing Process Engineer to join our team.

Salary and Benefits
The estimated annual salary for this position is $85,000 - $110,000, depending on experience. Our comprehensive benefits package includes health insurance, 401(k) matching, and paid time off.

Job Description
As a Manufacturing Process Engineer at Endotronix, you will be responsible for developing and controlling the manufacturing process for our Cordelia System and Cordella Pulmonary Artery Sensor System (Cor PASS). Your key responsibilities will include:
  • Supporting process development activities to account for design changes, performance improvements, and mitigations to the product.
  • Developing, authoring, reviewing, and executing production documentation, including manufacturing process instructions, inspections, specifications, and drawings.
  • Participating in CAPA investigations, NCR resolutions, and other investigation activities.
  • Gathering, organizing, and analyzing data.
  • Training personnel on production procedures.
  • Authoring and maintaining risk documentation for the manufacturing process and product.
  • Performing and supporting Design Transfer activities to manufacturing, including all aspects of Process Validation.
  • Acquiring and validating capital equipment, performing hands-on equipment troubleshooting.
  • Developing and participating in process tracking metrics to drive process improvements.

Requirements and Qualifications
To be successful in this role, you will need:
  • 0-3 years of medical device engineering experience preferred.
  • A working knowledge of ISO and FDA guidelines and requirements.
  • The ability to work independently with minimal supervision.
  • Excellent oral and written communication skills, particularly in technical writing and documentation.
  • Demonstrated organizational, interpersonal, and critical thinking skills.
  • A strong background in mechanical, electrical, or software design.
  • Experience with statistical data analysis.
  • Proficiency with Microsoft Office Suite.
  • Experience with SolidWorks, Minitab, Labview, MATLAB preferred.

LIFE AT ENDOTRONIX
Endotronix is an equal opportunity employer committed to providing equal employment opportunities to all persons without regard to race, creed, color, religion, national origin, sex, marital status, citizenship status, age, veteran status, or disability.

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