Engineer I, Manufacturing

Edwards Lifesciences Gruppe; Irvine (CA); Presencial; USD 69.000 - 98.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive salaries

Performance-based incentives

Benefits programs

Descripción de la vacante

Edwards Lifesciences Irvine is seeking an Engineer to lead optimization, validation, and lifecycle support of heart valve manufacturing processes across multiple product lines. You will own valve assembly manufacturing processes, equipment, and product quality, and drive process improvements to enhance yield, quality, ergonomics, throughput, and labor efficiency.

The role requires a Bachelor's in engineering or science, manufacturing experience in a regulated environment, and on-site

Formación

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

Responsabilidades

• 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.

Conocimientos

Manufacturing engineering

Process validation

DFM

FDA guidelines

EH&S guidelines

Communication skills

Problem solving

Educación

Bachelor's degree in engineering or scientific

Master's degree in Mechanical or Biomedical or MBA

Herramientas

MS Office Suite

Descripción del empleo

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‑functionally, 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.

Benefits:

• competitive salaries
• performance‑based incentives
• 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). 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.