Engineer I, Manufacturing

Edwards Lifesciences • Irvine, CA

3d • $69,000 - $98,000 • Onsite

About The Position

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. The role provides technical ownership of valve assembly manufacturing processes, equipment, and product quality, and supports process improvements, investigations, validations, commercialization, and scale-up. The position requires an on-site presence to collaborate cross-functionally and support manufacturing operations.

Requirements

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

Nice To Haves

• Master’s degree; MBA, Mechanical, or Biomedical degree.
• Class III medical device manufacturing experience.
• Technical skillset in manufacturing engineering, including 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.

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 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.

Benefits

• Competitive salaries.
• Performance-based incentives.
• A wide variety of benefits programs to address the diverse individual needs of employees and their families.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level