Manufacturing Maintenance & Validation Engineer

Edwards Lifesciences Gruppe; Draper (KY); On-site; USD 60,000 - 90,000; Full time

Job summary

Edwards Lifesciences seeks a hands-on maintenance and validation specialist to support equipment reliability and process improvements in a manufacturing setting in Kentucky. You will troubleshoot, perform preventive maintenance, and lead validation projects while ensuring compliance with GDP and quality standards.

The role requires strong documentation skills, collaboration with Quality and Engineering, and effective communication to drive continuous improvement in a medical device environment.

Qualifications

• High school diploma or equivalent with related experience; or an associate degree with related experience.
• Prior manufacturing and/or medical device experience preferred.
• Strong troubleshooting and problem-solving abilities; good documentation practices (GDP).
• Proficient with MS Office; CAD experience beneficial.

Responsibilities

• Troubleshoot and perform maintenance to minimize downtime and support validation.
• Design, set-up and execute feasibility studies and tests for equipment validation and process improvement.
• Lead projects on equipment validation and investigations; document findings and dispositions.
• Perform preventive maintenance on a range of equipment; validate operation and reduce downtime.
• Investigate failures and write impact assessment reports; implement corrective actions.
• Collaborate with Quality on corrective actions, EWOs, ENCRs, and OOTs.
• Review and move documentation to appropriate locations (ECRs, SOPs, drawings, tooling).
• Update documentation in systems using manufacturing software (JDE, QMS, PLM).
• Collaborate with Engineering to develop new basic tools; provide coaching to technicians.

Education

HS Diploma

Associate's Degree

Manufacturing/medical device experience

Troubleshooting

Documentation & GDP

MS Office

CAD (basic)

Tools

JDE

QMS

PLM

CAD software

Job description

Edwards Lifesciences seeks a hands-on maintenance and validation specialist to support equipment reliability and process improvements in a manufacturing setting in Kentucky. You will troubleshoot, perform preventive maintenance, and lead validation projects while ensuring compliance with GDP and quality standards.

The role requires strong documentation skills, collaboration with Quality and Engineering, and effective communication to drive continuous improvement in a medical device environment.