Engineer II, Manufacturing, Quality Assurance

Edwards Lifesciences Gruppe; Redhill (MD); On-site; USD 87,000 - 123,000; Full time

Job summary

Edwards Lifesciences is seeking an Engineer II, Manufacturing Quality Assurance to lead investigations, drive CAPAs, and improve process quality in a highly regulated environment. The role focuses on root cause analysis, corrective actions, and risk management within the CAPA framework. Onsite support to manufacturing operations is required, with emphasis on product quality and regulatory compliance.

Qualifications

• Bachelor's degree in Engineering or Science required.
• 2 years of hands-on experience solving manufacturing or quality challenges.
• Onsite presence required in manufacturing operations.

Responsibilities

• Lead investigations into manufacturing quality and compliance issues (CAPAs, nonconformances, audits).
• Perform root cause analysis and drive corrective actions to improve product quality and safety.
• Drive continuous improvement across manufacturing using Lean Six Sigma methodologies.
• Develop, update, and maintain risk management documentation throughout the product lifecycle.
• Mentor technicians and coordinate testing activities to support engineering projects.

Skills

CAPA investigations

Root cause analysis

Lean Six Sigma

Quality assurance

Education

Bachelor's degree in Engineering or Science

Tools

MS Office

MS Project

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’ll partner 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).

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

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world‑class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient‑focused culture to deliver life‑changing innovations to those who need them most.