Engineer II, R&D, Packaging Test Lab

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

Imagine how your ideas and expertise can change a patient’s life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You will play a key role in advancing Edwards' Packaging Test Laboratory capabilities through technical leadership, innovation, and continuous improvement. This position combines hands‑on engineering, laboratory testing, validation, and automation to support the development and commercialization of life‑saving medical technologies.

How you’ll make an impact:

• Design, execute, and document package testing and validation activities to support product development, manufacturing, supplier qualification, process changes, and regulatory requirements.
• Develop, validate, and continuously improve test methods, protocols, work instructions, fixtures, and laboratory processes for sterile and non‑sterile medical device packaging systems.
• Analyze test data using statistical and engineering principles; identify trends, investigate anomalies, and provide technical recommendations to internal customers and project teams.
• Lead or support equipment qualification activities (IQ/OQ/PQ), method validations, and laboratory investigations to ensure compliance with quality system and regulatory requirements.
• Drive laboratory process improvement and automation initiatives, including workflow optimization, digital data collection, data analytics, test scheduling, and implementation of laboratory technologies that improve efficiency, quality, and throughput.
• Support management of external testing suppliers by defining technical requirements, reviewing supplier test reports, and ensuring quality and service expectations are met.
• Provide technical direction and day‑to‑day guidance to technicians, including test execution, troubleshooting, training, workload coordination, and continuous skills development.
• Other duties assigned by Leadership.

What you’ll need (Required):

• Bachelor's Degree in Engineering or Scientific field with 2 years experience or
• Master's Degree or equivalent in Engineering or Scientific field with internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education.

What else we look for (Preferred):

• Experience with laboratory testing environments, engineering test methods, validation activities, troubleshooting, maintenance coordination, calibration oversight or medical device product testing.
• Knowledge of statistical methods and data analysis tools (e.g., Minitab, Excel, Power BI, or similar platforms).
• Experience improving business processes through automation, digital transformation, workflow optimization, data analytics, or software‑enabled solutions.
• Familiarity with regulated environments and quality systems, including design controls, validation principles, change control, CAPA, and good documentation practices.
• Strong technical writing skills with the ability to prepare protocols, reports, work instructions, requirement specifications, risk assessments, engineering records, design control deliverables and validation documentation.
• Ability to manage multiple projects simultaneously while balancing technical, quality, regulatory, and business requirements.
• Strong problem‑solving, root cause investigation, and critical thinking skills.
• Ability to collaborate effectively with cross‑functional stakeholders, external suppliers, and project teams.
• Experience with medical device packaging, package validation, transportation testing, environmental conditioning, sterilization validation support, or related laboratory activities is preferred.
• Experience with automation, scripting, AI‑enabled tools, databases, Power Platform applications, or laboratory information management systems (LIMS) is preferred.
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.

Aligning our overall business objectives with performance, we offer competitive salaries, performance‑based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $87,000 - $123,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.