Engineer I, Manufacturing

Edwards Lifesciences; Irvine (CA); On-site; USD 69,000 - 98,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA is seeking a Manufacturing Engineer to own valve assembly processes across Surgical, THV, and TMTT lines. You will lead validation, equipment qualification, and continuous improvement, partnering with Operations, Quality, Regulatory, Supply Chain, and R&D.

Requirements: Bachelor’s degree in engineering or science; manufacturing experience in a highly regulated environment; on-site presence.

Qualifications

• Bachelor’s degree in engineering or scientific field required.
• Manufacturing experience in a highly regulated environment.
• On-site presence required to effectively collaborate cross-functionally.

Responsibilities

• Provide technical ownership of valve assembly manufacturing processes, equipment, and product quality.
• Support complex process improvement initiatives to improve yield, quality, ergonomics, throughput, and labor efficiency.
• Participate in manufacturing investigations, NCRs, CAPAs, and root cause analyses using structured problem-solving methods.
• Develop, execute, and document process validations and equipment qualifications (IQ/OQ/PQ).
• Support commercialization, design transfer, and scale-up of new valve products and manufacturing technologies.
• Assess manufacturing risks and implement sustainable corrective and preventive actions.
• Partner with cross-functional teams to resolve complex technical issues, drive project execution, and develop scalable manufacturing processes.

Skills

Manufacturing experience

Cross-functional collaboration

On-site collaboration

MS Office Suite

DFM

EH&S guidelines

FDA guidelines

Process validation

Education

Bachelor’s degree in engineering or science

Tools

MS Office Suite

Job description

USA - California - Irvine

Full time

Req-51682

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 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 patient lives.

The Engineer will lead the optimization, validation, and lifecycle support of heart valve manufacturing processes across Surgical, Transcatheter Heart Valve (THV), and Transcatheter Mitral & Tricuspid Therapies (TMTT) product lines.

How you'll make an impact:

• Provide technical ownership of valve assembly manufacturing processes, equipment, and product quality.
• Support complex process improvement initiatives to improve yield, quality, ergonomics, throughput, and labor efficiency.
• Participate in manufacturing investigations, NCRs, CAPAs, and root cause analyses using structured problem-solving methods.
• Develop, execute, and document process validations and equipment qualifications (IQ/OQ/PQ).
• Support commercialization, design transfer, and scale-up of new valve products and manufacturing technologies.
• Assess manufacturing risks and implement sustainable corrective and preventive actions.
• Partner with cross-functional teams, including Operations, Quality, Regulatory, Supply Chain, and R&D, to resolve complex technical issues, drive project execution, and develop scalable manufacturing processes that support product quality, regulatory compliance, operational efficiency, and successful product launches.

What you'll need (Required):

• Bachelor’s degree in engineering or scientific.
• Manufacturing experience in a highly regulated environment.
• On-site presence required to effectively collaborate cross-functional, and support manufacturing operations.

What else we look for (Preferred):

• Master’s degree; MBA, Mechanical, or Biomedical degree.
• Class III medical device manufacturing experience.
• Technical skillset in manufacturing engineering: design for manufacturability (DFM), EH&S guidelines, FDA guidelines, and process validation.
• Experience with scale-up and manufacturing implementation initiatives.
• Effective communication and interpersonal skills at all levels of employees, suppliers, and consultants.
• Excellent documentation, communication, and interpersonal relationship skills including negotiating and relationship management.
• Advanced problem-solving, organizational, analytical, and critical thinking skills.
• Proven expertise in MS Office Suite.

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 $69,000 to $98,000 (highly experienced).

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.