Senior Software Validation Engineer – Quality & Compliance

Edwards Lifesciences Gruppe; Draper (UT); On-site; USD 90,000 - 120,000; Full time

Job summary

Edwards Lifesciences seeks a Senior Quality Engineer, Software Validation to lead software-quality efforts across Draper manufacturing and engineering teams. You will own validation strategies, review ESS and lifecycle docs, and ensure compliance with quality and regulatory standards.

The role partners with cross-functional teams to assess software needs, develop protocols, execute tests, evaluate results, and document deviations. A strong background in VBA is a plus.

Qualifications

• Bachelor’s or Master’s degree with relevant experience in software quality and validation.
• Experience in regulated manufacturing environments and software lifecycle activities.
• Strong documentation and problem-solving skills.

Responsibilities

• Lead software-quality and validation requests across teams.
• Develop, review, and approve software specifications and validation docs.
• Perform risk assessments and contribute to CAPA activities.

Skills

Software validation

Quality engineering

Regulatory compliance

Cross-functional collaboration

VBA programming

Education

Bachelor’s degree in engineering, science, CS, or information systems

Master’s degree in engineering, science, CS, or information systems

Tools

LabVIEW

Manufacturing execution systems

Job description

Edwards Lifesciences seeks a Senior Quality Engineer, Software Validation to lead software-quality efforts across Draper manufacturing and engineering teams. You will own validation strategies, review ESS and lifecycle docs, and ensure compliance with quality and regulatory standards.

The role partners with cross-functional teams to assess software needs, develop protocols, execute tests, evaluate results, and document deviations. A strong background in VBA is a plus.