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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

Job Description

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 hardware engineering, process improvement, and quality assurance in a regulated medical device environment.

The ideal candidate will lead manufacturing engineering initiatives, working with PCB assembly and managing electronic manufacturing processes for Class-III medical devices. They will be responsible for implementing design-for-manufacture improvements, troubleshooting production issues, and developing automated systems to enhance reliability and throughput.

This role offers an opportunity to make a direct impact on patient care through manufacturing excellence. The position requires a blend of technical expertise in electronics manufacturing, quality systems knowledge, and leadership skills. The successful candidate will work closely with R&D, Quality, and Manufacturing teams while maintaining compliance with FDA and ISO requirements.

Edwards Lifesciences offers a competitive compensation package, with a salary range of $106,000 to $149,000 for highly experienced candidates, plus performance incentives and comprehensive benefits. The company's commitment to patient care and innovation makes this an ideal opportunity for someone passionate about combining engineering expertise with meaningful healthcare impact.

The position is based in Naperville, Illinois, and requires COVID-19 vaccination for patient-facing roles. Edwards Lifesciences maintains extensive operations globally and employs over 15,000 individuals worldwide, providing opportunities for growth and development within a leading medical technology company.

Last updated 19 days 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
  • Define and develop automated and semi-automated systems & processes

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, etc.)
  • Strong background in mechanical, electrical or software design
  • Excellent oral and written communication skills

Benefits For Sr Engineer, Manufacturing

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