Engineer II, Manufacturing, Quality Assurance

Edwards Lifesciences; Irvine (CA); On-site; USD 87,000 - 123,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA is seeking an Engineer II, Manufacturing Quality Assurance to lead CAPA investigations, root cause analysis, and corrective actions that strengthen quality, compliance, and manufacturing performance.

In this onsite role, you will partner with Manufacturing, Quality and Engineering to drive Lean Six Sigma initiatives, risk management documentation, and process improvements across the product lifecycle to protect patient outcomes.

Qualifications

• Bachelor's degree in Engineering or Scientific field required.
• 2+ years of hands-on experience solving manufacturing or quality challenges in a highly regulated environment recommended.
• Experience leading investigations, CAPAs, and driving process improvements.

Responsibilities

• Lead investigations into manufacturing quality and compliance issues, including CAPAs, nonconformances, and audit observations.
• Perform root cause analysis, develop effective solutions, and drive actions that improve product quality, patient safety, and regulatory compliance.
• Drive continuous improvement initiatives across manufacturing operations using Lean and Six Sigma methodologies.
• Partner with cross-functional teams to assess and mitigate product and process risks by developing, updating, and maintaining risk management documentation.
• Create and improve manufacturing documentation, work instructions, and training materials.
• Provide technical guidance and mentorship to technicians, coordinate testing, and support engineering projects.

Skills

Root cause analysis

Investigations

Continuous improvement

Cross-functional collaboration

Lean Six Sigma

Education

Bachelor's degree in Engineering or Scientific field

Tools

MS Office

MS Project

Job description

Imagine how your ideas andexpertisecan change a patient’s life. Our GlobalOperations &Qualityteam plays a central part in ensuring our products are delivered to patients with cardiovascular disease.You’llpartner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world.

Make a direct impact on product quality and patient outcomes as an Engineer II, Manufacturing Quality Assurance supporting the CAPA team within Irvine Implant Manufacturing. In this role, you'll lead investigations, identify root causes, and drive corrective actions that strengthen quality, compliance, and manufacturing performance.

How you will make an impact:

• Lead investigations into manufacturing quality and compliance issues, including CAPAs, nonconformances, and audit observations. Perform root cause analysis, develop effective solutions, and drive actions that improve product quality, patient safety, and regulatory compliance.

• Drive continuous improvement initiatives across manufacturing operations using Lean and Six Sigma methodologies. Identify opportunities to optimize processes, reduce risk, improve efficiency, and enhance overall manufacturing performance.

• Partner with cross-functional teams to assess and mitigate product and process risks by developing, updating, and maintaining risk management documentation throughout the product lifecycle.

• Create and improve manufacturing documentation, work instructions, and training materials to support process consistency, operational excellence, and effective knowledge transfer.

• Provide technical guidance and mentorship to technicians, coordinate testing activities, support execution of engineering projects, and help develop team capabilities through training and coaching.

• Collaborate with Manufacturing, Quality, and Engineering teams to implement sustainable solutions that strengthen product quality.

What you’ll need:

• Bachelor's degree in Engineering or Scientific, with 2 years of hands-on experience solving manufacturing or quality challenges, leading investigations, and driving process improvements in a highly regulated environment.

• Onsite presence is required as this role provides direct support to manufacturing operations.

What else we look for:

• Medical device industry is preferred.

• Lean Six Sigma Certification is preferred.

• Experience with engineering methods (e.g., Six Sigma, LEAN methods, process flow charts, value stream mapping, statistics, and validation) for problem solving, continuous process improvement and sustaining manufacturing support.

• Understanding statistical and Six Sigma Techniques (Control Charting, DOE, Hypothesis Testing, Gage R&R, Z-Score, Tolerance Analysis, COV, Regression).

• Demonstrated use of process and design excellence methodologies to optimize processes and Operations Efficiency.

• Good computer skills in usage of MS Office Suite including MS Project.

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 (CA), the base pay range for this position is $87,000 to $123,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).