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Manufacturing Engineering Manager

2 months ago

Naperville, Illinois, United States Endotronix Full time
Job Title: Manufacturing Engineering Manager

We are seeking a highly skilled Manufacturing Engineering Manager to lead our team in the development and implementation of manufacturing processes for our medical devices.

Key Responsibilities:
  • Lead direct and indirect reporting individuals on team-based and project-based activities
  • Develop and implement process development activities to improve design changes, performance, and yield
  • Lead and support in-house manufacturing of products through the development of production documentation
  • Participate in CAPA investigations, NCR resolutions, and other investigation activities
  • Train personnel on production procedures
  • Author and maintain risk documentation for the manufacturing process and product
  • Perform and support Design Transfer activities to manufacturing, including Process Validation
  • Acquire and validate capital equipment
  • Develop and participate in process tracking metrics to drive process improvements
Requirements:
  • 3-5 years of medical device engineering experience
  • Working knowledge of ISO and FDA guidelines and requirements
  • Demonstrated ability to work independently with minimal supervision
  • Excellent oral and written communication skills
  • Demonstrated organizational, interpersonal, and critical thinking skills
  • Strong background in mechanical or electrical design
  • Experience with statistical data analysis
  • Proficiency with Microsoft Office Suite
About Us:

Endotronix is a medical device company that aims to transform the treatment of heart failure. We are passionate about leveraging data to deliver innovative solutions at scale.

We provide a competitive compensation package, comprehensive benefits, and an environment that will help you to thrive and succeed in your career.

We are an equal opportunity employer and 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.