Senior Medical Device Engineer

2 days ago


Naperville, Illinois, United States Endotronix, Inc Full time
Job Title: Systems Engineer II

About the Role:

We are seeking a highly skilled Systems Engineer II to join our Research & Development team at Endotronix, Inc. As a key member of our team, you will be responsible for designing and developing new products, managing risks, and improving product performance for the Cordella platform.

Key Responsibilities:

  • Product Development Activities:
    • Verification and validation testing, including test method development, protocol writing, test execution, data analysis, and report writing
    • Design change impact assessments
    • Risk management activities, including Hazard Analysis, Design FMEAs, and Use FMEAs
    • Standards compliance
    • User research and usability assessments/validation
    • Build and maintain the design history file
  • Troubleshooting and Problem Solving:
    • Troubleshoot device problems and test failures
    • Develop strategies and solutions to navigate the design and development process
  • Act as technical resource for field support

Requirements:

  • 3-5 years medical device engineering experience
  • Prior experience performing testing to support V&V and risk management activities for medical device development
  • Prior experience working within Design Controls and DHF ownership
  • Prior experience processing, parsing, and analyzing data, including script development for automation and statistical analysis methods using Excel and Minitab
  • Demonstrated ability to work independently with minimal supervision
  • Excellent oral and written communication skills, particularly in technical writing, documentation, and presentations
  • Demonstrated organizational, interpersonal, and critical thinking skills
  • Experience with medical devices and FDA quality practices and standards, including ISO 13485

What We Offer:

  • Competitive compensation package
  • Comprehensive benefits, including unlimited PTO
  • A dynamic and collaborative work environment
  • Opportunities for growth and professional development

About Us:

Endotronix, Inc. is a medical device company dedicated to transforming the treatment of heart failure. We are passionate about delivering innovative solutions that improve patient quality of life and reduce healthcare costs. Join our team and be part of a mission-driven organization that values collaboration, innovation, and excellence.



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