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Sr Engineer, Manufacturing

Global leader in patient-focused medical innovations for structural heart disease, critical care and surgical monitoring.
Naperville, IL, USA
$106,000 - $149,000
Embedded
Senior Software Engineer
In-Person
5,000+ Employees
5+ years of experience
Healthcare · Biotech

Description For Sr Engineer, Manufacturing

Edwards Lifesciences, the global leader in patient-focused medical innovations for structural heart disease, is seeking a Senior Manufacturing Engineer to join their Implantable Heart Failure Management (IHFM) team. This role focuses on electronics assembly of the Cordella Patient Reader, a critical medical device that helps heart failure patients.

The position combines software engineering with manufacturing expertise, requiring deep knowledge of PCB assembly, electronic systems, and medical device regulations. You'll lead manufacturing engineering initiatives, working closely with R&D, Quality, and Manufacturing teams to ensure high-quality production of Class-III medical devices.

Key responsibilities include process development, automation implementation, root cause analysis, and maintaining comprehensive documentation for regulatory compliance. The role requires strong technical skills in both hardware and software, with experience in tools like LabVIEW, MATLAB, and statistical analysis software.

This is an excellent opportunity for an experienced engineer passionate about improving patient outcomes through innovative medical technology. The position offers competitive compensation ($106,000-$149,000), comprehensive benefits, and the chance to work with cutting-edge medical devices at a company with over 15,000 employees worldwide.

Located in Naperville, Illinois, you'll be part of a team dedicated to transforming patient care through pioneering technology. The role requires COVID-19 vaccination due to its patient-facing nature and demands a thorough understanding of FDA and ISO guidelines. If you're excited about combining engineering expertise with meaningful impact on healthcare, this position offers both technical challenges and the satisfaction of improving patients' lives.

Last updated a month ago

Responsibilities For Sr Engineer, Manufacturing

  • Lead and support process development activities for Class-III medical device product
  • Lead and support in-house manufacturing through development and documentation
  • Lead root cause investigations and CAPA/NCR corrective actions
  • Author and maintain risk documentation for manufacturing process and product
  • Perform and support Design Transfer activities to manufacturing
  • Write and Execute Process Validation of Equipment and Manufacturing Processes
  • Design, develop and fabricate test fixtures for process improvements
  • Work with PCB assembly and fab house vendors to improve yield
  • Troubleshoot high-priority field and production issues

Requirements For Sr Engineer, Manufacturing

Linux
  • Bachelor's Degree in related field
  • 5 years experience in manufacturing environment involving electronic/software process improvements
  • Working knowledge of ISO and FDA guidelines
  • Experience with statistical data analysis
  • Experience with SolidWorks, Minitab, LabVIEW, and/or MATLAB
  • Proficiency with Microsoft Office Suite
  • Risk analysis experience (PFMEA, DFMEA)
  • Strong background in mechanical, electrical or software design
  • Excellent oral and written communication skills
  • COVID-19 vaccination required for patient-facing roles

Benefits For Sr Engineer, Manufacturing

Medical Insurance
  • Competitive salaries
  • Performance-based incentives
  • Various benefits programs for employees and families

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