Senior EOL Test Validation Engineer

About the role

The Senior EOL Test Validation Engineer will support new product and process introductions, ensuring compliance with Product Development Process, Design Controls, and Quality System requirements. This hybrid position collaborates across R&D, Manufacturing, Quality, Regulatory, and Operations to industrialize and transfer products into manufacturing.

Key responsibilities

• Develop, execute, and maintain validation documentation including Validation Plans, Risk Assessments, Protocols, Traceability Matrices, and Final Reports.
• Lead Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for equipment, processes, tooling, fixtures, and production systems.
• Support manufacturing readiness activities such as pilot builds, process characterization, verification, and production ramp‑up.
• Ensure all validation activities comply with GMP, FDA QSR (21 CFR 820), ISO 13485, ISO 60601, and internal quality standards.

Required profile

• Bachelor's degree in Mechanical, Electrical, Electronics, Industrial, Manufacturing Engineering or related field.
• Minimum 6 + years experience in Validation, Manufacturing, or Quality Engineering within regulated industries.
• Hands‑on experience executing IQ/OQ/PQ protocols and reviewing test requirements derived from product specifications.
• Experience with New Product Development, design transfer, and manufacturing scale‑up.

Required skills

• IQ/OQ/PQ execution
• Validation Plans, Risk Assessments, Protocols, Traceability Matrices
• GMP, FDA QSR (21 CFR 820), ISO 13485, ISO 60601
• PFMEA, Control Plans, PPAP
• MSA, Gage R&R, process capability analysis, Minitab
• Computer System Validation (CSV) methodologies