Principal Engineer, Supplier Development – Implantable Tech

Edwards Lifesciences

Irvine (CA)

On-site

USD 121,000 - 171,000

Full time

14 days+

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Benefits offered by this job

Health insurance

Job summary

Edwards Lifesciences in California is seeking a Principal Engineer for the Implantable Heart Failure Management (IHFM) team. You will lead supplier validation, drive design for manufacturability, and partner across R&D, Manufacturing, and Quality to deliver compliant, timely results for next-generation catheter delivery systems.

The role requires strong project management, Design Control expertise, and experience in regulated medical device development.

Qualifications

  • Bachelor’s degree in engineering or science with 6 years of experience in new product development, process development, commercialization, and/or operations engineering in a highly regulated environment.
  • Willingness to travel up to 25% domestically and internationally.
  • On-site work is required.
  • Master’s degree in engineering and/or MBA, Lean Six Sigma certification preferred.

Responsibilities

  • Lead end-to-end supplier validation and product development with GD&T reviews and process validation.
  • Build partnerships with R&D, PM, Manufacturing, Supplier Quality, and suppliers to ensure compliant execution.
  • Contribute to next-generation IHFM systems and components.
  • Lead cross-functional teams and external suppliers in design, development, and testing of complex interventional catheter delivery systems for implantable devices.
  • Oversee feasibility studies, design verification testing, clinical evaluations, and supplier validation for commercial release.
  • Perform other duties as assigned.

Skills

Design control
GD&T
Six Sigma
ISO 13485
Risk management
DFM
DFA
Vendor management
Rapid development
Interventional devices

Education

Bachelor's degree in engineering or science
Master's degree in engineering and/or MBA

Job description

Edwards Lifesciences in California is seeking a Principal Engineer for the Implantable Heart Failure Management (IHFM) team. You will lead supplier validation, drive design for manufacturability, and partner across R&D, Manufacturing, and Quality to deliver compliant, timely results for next-generation catheter delivery systems.

The role requires strong project management, Design Control expertise, and experience in regulated medical device development.

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