Senior Software Validation Engineer – Manufacturing

Edwards Lifesciences; Salt Lake City, Northern (UT, KY); Hybrid; USD 120,000 - 160,000; Full time

Job summary

Edwards Lifesciences in Draper seeks a Senior Quality Engineer, Software Validation to lead software-quality and validation activities across manufacturing and engineering teams, ensuring compliance.

The role includes developing and approving software specifications, protocols, risk assessments, and supporting validation reports, while representing Draper in cross-site governance for global standards and lifecycle documentation.

Qualifications

• Bachelor's degree in an engineering, scientific, computer science, or information systems field with 4+ years of relevant experience.
• Experience supporting software quality, software validation, computer system validation, or software lifecycle activities in a regulated manufacturing environment.
• Experience in a highly regulated environment.

Responsibilities

• Lead and manage software-quality and validation requests from manufacturing and engineering teams.
• Develop, review, maintain, and approve Edwards Software Specifications (ESS) and other software lifecycle documentation.
• Represent the Draper facility on cross-site governance for global software-validation standards.
• Provide technical guidance on software lifecycle controls, validation approaches, and documentation requirements.
• Investigate software-quality issues, CAPAs, deviations, and audit observations.

Skills

Software validation

Cross-functional collaboration

VBA scripting

Regulatory compliance

Risk management

Education

Bachelor's degree in engineering/science/CS/IS

Master's degree in engineering/science/CS/IS

Tools

LabVIEW

PLC

Job description

Edwards Lifesciences in Draper seeks a Senior Quality Engineer, Software Validation to lead software-quality and validation activities across manufacturing and engineering teams, ensuring compliance.

The role includes developing and approving software specifications, protocols, risk assessments, and supporting validation reports, while representing Draper in cross-site governance for global standards and lifecycle documentation.