Engineer II, R&D, Packaging Test Lab

Edwards Lifesciences • Irvine, CA

6d

About The Position

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. The R&D Packaging Test Lab Engineer II will lead test method development, equipment qualification, process optimization, and digital transformation projects while collaborating with cross-functional teams and external partners to deliver high-quality, compliant, and efficient testing solutions.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• 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.
• 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.

Benefits

• competitive salaries
• performance-based incentives
• a wide variety of benefits programs to address the diverse individual needs of our employees and their families

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level