Senior Software Validation Engineer

Edwards Lifesciences Gruppe

Draper (UT)

On-site

USD 110,000 - 160,000

Full time

14 days+

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Job summary

Edwards Lifesciences is seeking a Senior Quality Engineer, Software Validation to lead software quality and validation activities for production and non‑product software at the Draper facility. You will partner with manufacturing, engineering, and cross‑functional teams to define validation strategies and ensure lifecycle documentation meets quality and regulatory standards.

The role involves developing and reviewing software specifications, supporting validation protocols, and representing the

Qualifications

Bachelor’s degree required in engineering, science, CS, or information systems with ≥4 years of experience; or Master’s with ≥3 years.
Experience in software quality, software validation, computer system validation, or software lifecycle activities in a regulated manufacturing environment.
Experience in highly regulated environments is preferred.

Responsibilities

Lead software quality and validation requests from various teams, ensuring proper validation strategies and lifecycle documentation.
Develop, review, and approve Edwards Software Specifications and validation plans and reports.
Represent the Draper facility in cross-site governance for software validation standards and process changes.