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Edwards Lifesciences

via Workday

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Senior Engineer, Manufacturing

Irvine, California
Full-time
Posted 12/1/2025
Direct Apply
Key Skills:
Manufacturing Engineering
Process Optimization
Equipment Validation
Manufacturing Execution System (MES)
Lean/Black Belt
Regulatory Compliance (FDA, EH&S)
Project Management
Problem Solving
Communication

Compensation

Salary Range

$106K - 149K a year

Responsibilities

Lead and support manufacturing engineering activities including process optimization, equipment validation, production troubleshooting, and continuous improvement in a medical device manufacturing environment.

Requirements

Bachelor's degree in engineering or scientific field with 4 years manufacturing engineering experience in a regulated industry, on-site work required, preferably with mechanical or biomedical background and Lean or Black Belt certification.

Full Description

Imagine how your ideas and expertise can change a patient’s life. Our Global Supply Chain 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 meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patients’ lives. Join our Irvine Implant Manufacturing Plant and make an impact by supporting the RESILIA Value Stream, which produces THV, Surgical, and TMTT heart valves. This role offers an exciting opportunity to be part of a dynamic cross-functional team focused on safety, quality, delivery, and cost. As a Senior Manufacturing Engineer, you will contribute to sustaining operations and lead continuous improvement initiatives that drive efficiency and excellence. How you’ll make an impact: Lead and support diverse engineering activities, including process optimization, equipment validations, production line troubleshooting, and enhancements to the Manufacturing Execution System (MES). Collaborate with cross-functional teams to ensure operational excellence in safety, quality, delivery, and cost, while driving sustaining initiatives and continuous improvement efforts. Manage engineering projects across the Global Supply Chain Implant Network, from new product introduction through stabilization and ongoing sustaining activities. Analyze and resolve complex manufacturing and compliance challenges, such as CAPAs, non-conformances, and audit observations, ensuring adherence to regulatory standards. Contribute to strategic and operational goals by identifying opportunities for efficiency and implementing best practices across processes and systems. Perform additional responsibilities as needed to support team and organizational objectives. What you’ll need: Bachelor's Degree in Engineering or Scientific field with 4 years of manufacturing engineering experience Regulated industry experience. On-site required. What else we look for: Mechanical or Biomedical degree. Lean or Black Belt certification. Technical skillset in manufacturing engineering: design for manufacturability (DFM), EH&S guidelines, FDA guidelines, and process validation. Effective communication and interpersonal skills. Proven expertise in usage of MS Office Suite. Excellent documentation, communication, and interpersonal relationship skills including negotiating and relationship management. Problem-solving, organizational, analytical, and critical thinking skills. 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 $106,000 to $149,000 (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. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination. Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

This job posting was last updated on 12/5/2025

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