Engineer II, R&D, Packaging Test Lab

Imagine how your ideas and expertise can change a patients 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.

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.

How youll 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 youll need (Required):

• Bachelors Degree in Engineering or Scientific field with 2 years experience or
• Masters 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 $87000 - $123000 (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.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.