Principal Engineer, Medical Device NPD & Manufacturing

Edwards Lifesciences Gruppe

Irvine (CA)

On-site

USD 121,000 - 171,000

Full time

14 days+

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Job summary

Edwards Lifesciences in Irvine, CA, is seeking a Principal Engineer to lead the development of the next-generation balloon expandable delivery systems for THV. You will design manufacturing processes for Class II/III devices, apply design controls, and drive cross-functional validation.

You will collaborate with R&D, Manufacturing, Quality, and suppliers, lead scaling across sites, and shape automation and digital infrastructure.

Qualifications

Bachelor's or Master’s degree in Engineering or Science with 5–6+ years of related medical device manufacturing experience.
Hands-on experience with manufacturing operations for Class II/III devices and design controls.
Strong knowledge of cGMP and EH&S practices in a manufacturing environment.

Responsibilities

Develop manufacturing processes for balloon expandable delivery systems.
Design and execute experiments, analyze data, and establish process windows.
Lead validation strategies and execution for equipment, software, and processes.
Scale and replicate equipment and processes across sites with comparability studies.
Develop automation and digital infrastructure, including PLCs, SCADA, and MES.