Packaging Test Lab Engineer II - R&D & Validation

Edwards Lifesciences; Irvine, Northern (CA, KY); Hybrid; USD 87,000 - 123,000; Full time

Job summary

Edwards Lifesciences is seeking a Packaging Test Laboratory engineer to design, execute, and document tests for medical device packaging. You will develop test methods, fixtures, and lab processes for sterile and non‑sterile packaging systems, while analyzing data to deliver technical recommendations.

The role involves IQ/OQ/PQ activities, process improvements, and collaboration with cross‑functional teams to ensure regulatory compliance and high quality outcomes.

Qualifications

• Bachelor's degree in Engineering or a scientific field is required, with 2 years' experience or a Master's with relevant project work.
• Experience with laboratory testing environments and validation activities preferred.
• Knowledge of statistical methods and data analysis tools.
• Experience with automation, digital transformation, and data analytics.

Responsibilities

• Design, execute, and document package testing and validation activities.
• Develop and improve test methods, fixtures, and lab processes for packaging systems.
• Analyze test data and provide technical recommendations.
• Lead or support IQ/OQ/PQ and method validations.
• Drive lab process improvement and automation initiatives.
• Support management of external testing suppliers and QA.

Skills

Lab testing

Statistical analysis

Minitab

Excel

Power BI

Automation

Data analytics

LIMS

Education

Bachelor's degree in Engineering or Science

Master's degree or equivalent in Engineering or Science

Tools

Minitab

Excel

Power BI

LIMS

Job description

Edwards Lifesciences is seeking a Packaging Test Laboratory engineer to design, execute, and document tests for medical device packaging. You will develop test methods, fixtures, and lab processes for sterile and non‑sterile packaging systems, while analyzing data to deliver technical recommendations.

The role involves IQ/OQ/PQ activities, process improvements, and collaboration with cross‑functional teams to ensure regulatory compliance and high quality outcomes.