Senior Engineer, Manufacturing, Product and Process Engineering

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

Job summary

Edwards Lifesciences in Irvine, CA is seeking a Senior Engineer to shape manufacturing for THV/TMTT portfolios. You will lead qualification, installation, and validation of a new sterilization tank while coordinating with global teams to ensure compliant, efficient processes.

Role requires lean/six-sigma expertise and strong project management to drive equipment implementation, process validation, and continuous improvement across manufacturing operations.

Qualifications

• Bachelor's degree in Engineering or a scientific field with 4 years in manufacturing engineering.
• Onsite presence is required to support manufacturing operations.
• Experience in a highly regulated medical device environment is preferred.

Responsibilities

• Improve manufacturing processes using engineering methods for continuous improvement.
• Develop experiments and tests to qualify and validate processes; analyze results.
• Analyze and resolve CAPA, non-conformances, and audit observations.
• Develop work instructions and training materials for production.
• Lead cross-functional teams for equipment implementation and improvements.
• Create URS/CQ/IQ/OQ/PQ documentation to support validation activities.

Skills

LEAN methods

Six Sigma

Project management

Statistical analysis

CAPA

Process validation

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Science

Tools

MS Project

MS Office

MES

Job description

Imagine how your ideas andexpertisecan change a patient’s life. Our GlobalOperations &Qualityteam plays a central part in ensuring our products are delivered to patients with cardiovascular disease.You’llpartner 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.

The Senior Engineer will help shape the future of manufacturing for our Surgical, Transcatheter Heart Valve (THV), and Transcatheter Mitral & Tricuspid Therapies (TMTT) portfolios. As a Senior Engineer, you will play a key role in the installation, qualification, and implementation of a new sterilization tank while partnering with cross-functional teams in Irvine, Singapore, and Costa Rica. This high-impact position offers opportunities to lead equipment and process validation activities, drive new product introductions, support manufacturing operations, implement MES enhancements, and execute continuous improvement initiatives. The role requires close collaboration with Manufacturing Operations, Quality, Microbiology, Plant Operations Engineering, EHS, Supply Chain, and external suppliers to ensure compliant, efficient, and reliable manufacturing processes.

How you’ll make an impact:

• Improve manufacturing processes using engineering methods (e.g., LEAN methods, basic statistics) for continuous process improvement
• Develop basic experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports
• Analyze and resolve basic Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)
• Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
• Establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis)
• Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes
• Oversee manufacturing support tasks; give instruction to technicians, leads or operators on conducting tests; train technicians, leads or operators and provide feedback; and coordinate technician work
• Lead cross-functional internal teams as well as external suppliers to support equipment implementation, process improvements, and manufacturing readiness.
• Serve as the engineering lead for capital equipment projects including requirements definition, design reviews, supplier coordination, installation, commissioning, and manufacturing implementation.
• Develop and author User Requirement Specifications (URS), Construction Qualifications (CQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ) to support equipment and process validation activities in compliance with regulatory and company requirements.
• Support procurement of equipment, components, spare parts, and validation materials required for manufacturing operations and project execution.

What you’ll need:

• Bachelors’ Degree in Engineering or Scientific field required with 4 years of manufacturing engineering experience in a highly regulated environment.
• Onsite presence is required as this role provides direct support to manufacturing operations.

What else we look for:

• Medical device industry is preferred.
• Lean Six Sigma Certification is preferred.
• Experience supporting capital equipment projects from concept through implementation in a regulated manufacturing environment.
• Knowledge of sterilization processes, manufacturing equipment qualification, and process validation methodologies preferred.
• Strong project management and supplier management skills with demonstrated ability to coordinate activities across global sites.
• Experience with engineering methods (e.g., Six Sigma, LEAN methods, process flow charts, value stream mapping, statistics, and validation) for problem solving, continuous process improvement and sustaining manufacturing support.
• Strong understanding of basic statistics (mean, average, range, standard deviation, normality, confidence intervals, histograms).
• Understanding statistical and Six Sigma Techniques (Control Charting, DOE, Hypothesis Testing, Gage R&R, Z-Score, Tolerance Analysis, COV, Regression).
• Demonstrated use of process and design excellence methodologies to optimize processes and Operations Efficiency.
• Demonstrated use of DFM, Industrial Engineering and lean experience leading to manufacturing efficiency improvement.
• Good computer skills in usage of MS Office Suite including MS Project.

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 $108,000 to $153,000 (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.