Engineer I, Manufacturing

Reposted Yesterday
Be an Early Applicant
Irvine, CA, USA
In-Office
69K-98K Annually
Entry level
Healthtech • Pharmaceutical
The Role
Leads optimization, validation, and lifecycle support for heart valve manufacturing processes. Responsibilities include process improvement, manufacturing investigations, CAPA and root cause analysis, equipment qualification, commercialization, design transfer, scale-up, risk mitigation, and cross-functional collaboration to ensure quality, compliance, efficiency, and successful product launches.
Summary Generated by Built In

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.

 
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).


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.

Skills Required

  • 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
  • Master's degree, MBA, Mechanical Engineering, or Biomedical Engineering degree
  • Class III medical device manufacturing experience
  • Technical expertise in design for manufacturability, EH&S guidelines, FDA guidelines, and process validation
  • Experience with scale-up and manufacturing implementation initiatives
  • Effective communication and interpersonal skills with employees, suppliers, and consultants
  • Documentation, communication, negotiation, and relationship management skills
  • Advanced problem-solving, organizational, analytical, and critical-thinking skills
  • Proficiency with Microsoft Office Suite

Edwards Lifesciences Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Edwards Lifesciences and has not been reviewed or approved by Edwards Lifesciences.

  • Healthcare Strength — Health coverage is considered strong, with multiple plan choices, HSA options, and fertility support, and the company highlights holistic well‑being programs.
  • Retirement Support — A company 401(k) match and well‑regarded retirement offerings add clear long‑term value to total compensation.
  • Equity Value & Accessibility — An Employee Stock Purchase Plan with a discount and look‑back feature makes equity ownership accessible and enhances the total rewards package.

Edwards Lifesciences Insights

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The Company
HQ: Irvine, CA
13,687 Employees
Year Founded: 1958

What We Do

Edwards Lifesciences (NYSE: EW), is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more. Our roots date back to 1958 when Miles Lowell Edwards, a retired engineer with a background in hydraulics and fuel pump operations, set out to build the first artificial heart. Edwards believed the heart could be mechanized and was encouraged by Dr. Albert Starr to focus on developing an artificial heart valve. After just two years, the first Starr-Edwards mitral valve was developed and successfully placed in a patient. This innovation spawned Edwards Laboratories. Miles’ fascination with healing the heart and helping patients with heart disease stemmed from his own experience with rheumatic fever as a teenager and continues to fuel our patient-first culture today. Today, we are as passionate about providing innovative solutions for people fighting cardiovascular disease as we have ever been. It's our Credo. It takes integrity, collaboration, innovation, and focus. We are leaders in the design and manufacture of tissue replacement heart valves and repair products as well as advanced hemodynamic monitoring. We partner with physicians to innovate products designed to help patients live longer, healthier, and more productive lives. Our work is both rewarding and a privilege. The importance of what we do defines our approach. We work together to create an environment where ideas can flourish and we provide our people with the resources, expertise and support to bring those ideas to life. For our legal terms and trademarks, please visit: https://www.edwards.com/legal/legal-terms

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