Manufacturing Engineer II

3 weeks ago

Naperville, Illinois, United States Endotronix, Inc Full time
Job Overview

Endotronix, Inc. is seeking a highly skilled Manufacturing Engineer II to join our team. This role will be responsible for developing and controlling the manufacturing process for our Cordelia System and Cordella Pulmonary Artery Sensor System (Cor PASS).

Key Responsibilities
  • Lead and support process development activities to account for design changes, performance and yield improvements and mitigations to the product.
  • Develop, author, review, and execute production documentation (manufacturing process instructions, inspections, specification/drawings, routers, etc.).
  • Lead and/or participate in CAPA investigations, NCR resolutions, and other investigation activities.
  • Gather, organize, and analyze data.
  • Train personnel on production procedures.
  • Author and maintain risk documentation (PMEA, etc.) for the manufacturing process and product.
  • Perform and support Design Transfer activities to manufacturing, including all aspects of Process Validation.
  • Acquire and validate capital equipment. Perform hands-on equipment troubleshooting.
  • Develop and participate in process tracking metrics and use these to drive process improvements (Scrap/Yield Tracking, Cost Tracking, etc.).
  • Write and Execute Process Validation of Equipment and Manufacturing Processes in the forms of IQ/OQ/PQ.
  • Design, develop, and fabricate test fixtures for the purposes of manufacture and inspection.
  • Perform Test Method Validation of inspections including Gage R&R analysis.
  • Interact with vendors and suppliers to ensure timely completion of deliverables.
  • Perform additional related actions and duties as outlined and requested by management.
Requirements
  • 3-5 years medical device engineering experience preferred.
  • Working knowledge of ISO and FDA guidelines and requirements.
  • Demonstrated 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.
  • 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.
  • Risk analysis experience (PFMEA, DFMEA, etc.) preferred.
Education
  • BS in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Computer Engineering, or equivalent.
About Us

Endotronix, Inc. is a medical device company that aims to transform the treatment of heart failure. We are 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.

We do not tolerate any form of discrimination or harassment of our employees by co-workers, supervisors, customers, or vendors. This commitment extends to our policies on recruiting, advertising, hiring, placement, promotion, training, transfer, wages, benefits, termination, and all other privileges, terms, and conditions of employment.

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