Senior Engineer, Manufacturing

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 108,000 - 153,000; Full time

Benefits offered by this job

Competitive salary

Incentives program

Full benefits package

Job summary

Edwards Lifesciences is seeking a Senior Engineering Lead – Heart Valve Manufacturing in Irvine, CA. The role focuses on owning valve assembly processes, driving yield improvements, and supporting validations and scale-up across Surgical, THV, and TMTT lines.

You will collaborate with Operations, Quality, Regulatory, Supply Chain, and R&D to ensure product quality, regulatory compliance, and successful product launches.

Qualifications

• Bachelor’s degree in engineering or scientific field.
• On-site presence required for cross-functional collaboration.
• Lean or Black Belt certification preferred.
• ClassIII medical device manufacturing experience is a plus.

Responsibilities

• Provide technical ownership of valve assembly manufacturing processes and equipment.
• Lead complex process improvement initiatives to improve yield and throughput.
• Drive investigations, NCRs, CAPAs, and root cause analyses.
• Develop, execute, and document IQ/OQ/PQ validations and qualifications.
• Support design transfer and scale-up of new valve products and technologies.
• Collaborate with Operations, Quality, Regulatory, Supply Chain, and R&D to resolve issues.

Skills

Manufacturing engineering

Process validation

MS Office

Education

Bachelor’s degree in engineering or science

Tools

MS Office Suite

Job description

Role Overview

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.

Senior Engineering Lead – Heart Valve Manufacturing

The Senior 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.

Responsibilities

• Provide technical ownership of valve assembly manufacturing processes, equipment, and product quality.
• Lead complex process improvement initiatives to improve yield, quality, ergonomics, throughput, and labor efficiency.
• Drive 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

• Bachelor’s degree in engineering or scientific with 4 years of manufacturing experience in a highly regulated environment.
• On‑site presence required to effectively collaborate cross‑functionally, and support manufacturing operations.

Preferred Qualifications

• Master’s degree; MBA, Mechanical, or Biomedical degree.
• Lean or Black Belt certification.
• ClassIII medical device manufacturing experience.
• Strong technical skillset in manufacturing engineering: design for manufacturability (DFM), EH&S guidelines, FDA guidelines, and process validation.
• Experience leading scale‑up and manufacturing implementation projects.
• 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.

Benefits & Compensation

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.

Pay Range – California

For California, the base pay range for this position is $108,000 - $153,000 in tool (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

Equal Opportunity

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

About Edwards Lifesciences

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.