Principal Engineer, NPD

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 121,000 - 171,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA, is seeking a Principal Engineer to lead the development of the next-generation balloon expandable delivery systems for THV. You will design manufacturing processes for Class II/III devices, apply design controls, and drive cross-functional validation.

You will collaborate with R&D, Manufacturing, Quality, and suppliers, lead scaling across sites, and shape automation and digital infrastructure.

Qualifications

• Bachelor's or Master’s degree in Engineering or Science with 5–6+ years of related medical device manufacturing experience.
• Hands-on experience with manufacturing operations for Class II/III devices and design controls.
• Strong knowledge of cGMP and EH&S practices in a manufacturing environment.

Responsibilities

• Develop manufacturing processes for balloon expandable delivery systems.
• Design and execute experiments, analyze data, and establish process windows.
• Lead validation strategies and execution for equipment, software, and processes.
• Scale and replicate equipment and processes across sites with comparability studies.
• Develop automation and digital infrastructure, including PLCs, SCADA, and MES.

Skills

Manufacturing engineering

Data analysis

Cross-functional teamwork

Process validation

Troubleshooting

Education

Bachelor's degree in Engineering or Science

Master's degree in Engineering or Science

Tools

PLC

SCADA

MES

Automation systems

Job description

Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.The THV Balloon Expandable Delivery System New Product Development (NPD) team is looking for a Principal Engineer to support the development of our next-generation balloon expandable delivery systems. The Principal Engineer will have the opportunity to drive process design and characterization, work on a strong cross-functional team, and partner with the commercial site on process validations and commercialization activities.How you will make an impact:Develop manufacturing processes suitable for Class II/III medical devices; apply design controls, traceability, and change management throughout product development and commercialization.Design and execute experiments, analyze data, establish process windows, and continuously improve manufacturing capability using statistical and engineering methodologies.Lead validation strategies and execution for equipment, software, processes, and manufacturing systems.Develop scaling and replication approaches for equipment and processes across sites, including comparability studies to demonstrate equivalency between pilot and production environments.Develop approaches for scaling and replicating manufacturing equipment and processes across sites.Design and support manufacturing automation and digital infrastructure, including PLCs, SCADA, MES, industrial networking, and electronic records.Lead highly matrixed teams across organizations, functions, suppliers, and manufacturing locations.Serve as a trusted advisor across R&D, Manufacturing, Quality, Project Management, and suppliers; communicate risks, tradeoffs, and recommendations to build alignment and resolve complex challenges.What you'll need:Bachelor's Degree in Engineering or Scientific field with 6 years of related experience, including either industry or industry/education, ORMaster's Degree in Engineering or Scientific field with 5 years of related experience, including either industry or industry/education.What else we look for:Relevant experience and expertise working in the medical device industry, specifically within manufacturing operations and/or New Product Development.Demonstrated knowledge of catheter assembly process technologies, including adhesive bonding, thermal bonding, tube flaring, coatings, vision systems, plastics, metals, and related manufacturing technologies.Strong understanding of mechanical systems, sensors, actuators, pneumatics, motors, drives, controls, troubleshooting, and machine safety principles.Hands-on, execution-focused, comfortable operating in ambiguity, motivated by patient impact, and skilled at bridging innovation with manufacturing reality.Technical experience in a manufacturing engineering environment, including sound understanding of current Good Manufacturing Practices (cGMP) and Environmental Health & Safety (EH&S).Process development and excellence: Design for Manufacturability (DFM), Six Sigma, and LEAN.Prior experience working with supplier development teams.Excellent written and verbal communication and interpersonal skills, including negotiation and relationship management, with the ability to drive achievement of objectives.Expert understanding of critical-to-quality (CTQ) design elements, cascading CTQs to design inputs/outputs, and establishing process controls/limits.Experience with the development-through-commercialization process of medical devices.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 $121,000 to $171,000 (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.