Principal Engineer, Supplier Development

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 supplier validation and product development for our Implantable Heart Failure Management (IHFM) team. You will ensure DFMA, quality compliance, and timely project execution in a regulated medical device setting.

You will partner with R&D, Manufacturing, Supplier Quality, and key suppliers to drive design optimization, verification testing, clinical evaluations, and commercialization. Travel up to 25% is required.

Qualifications

• Bachelor's degree in engineering or a scientific field with 6 years in new product development or operations engineering.
• Willingness to travel up to 25% domestically and internationally.
• Experience in regulated medical device development and ISO 13485 quality systems.
• Lean Six Sigma certification or formal training is a plus.
• Strong problem-solving skills and cross-functional collaboration.

Responsibilities

• Lead end-to-end supplier validation and product development activities across design and process characterization.
• Drive design verification testing, clinical evaluations, and supplier validation for commercial release.
• Coordinate with R&D, Program Management, Manufacturing, and suppliers to ensure timely execution.
• Ensure compliance with QSR, FDA regulations, ISO 13485, and risk management practices.
• Oversee feasibility studies, testing timelines, and project milestones for IHFM devices.

Skills

Design Control

Project Management

Supplier Quality

Six Sigma

Cross-functional teamwork

Education

Bachelor's degree in engineering or scientific field

Master’s degree in engineering or MBA

Tools

GD&T

ISO 13485

Process validation

Job description

Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.The Principal Engineer will serve as a key technical subject matter expert, partnering closely with internal teams and external suppliers to ensure product designs meet user needs - including ease of use, manufacturability, cost effectiveness, and operational efficiency. In addition to deep technical leadership, this role requires strong project management capabilities and a thorough understanding of Design Control to drive effective, compliant, and timely project execution.How you’ll make an impact:Supplier Validation and Product Development Process: Lead the end-to-end technical validation of suppliers during product development, from component design and GD&T reviews to process characterization, capability analysis, and strategic process validation, ensuring robust DFM/DFA integration and quality compliance across all development stages.Build and maintain strong partnerships with R&D, Program Management, Manufacturing, Supplier Quality, and key suppliers to ensure seamless project execution and compliance with internal procedures, QSR, FDA regulations, ISO 13485 standards, and risk management best practices.Support and contribute to product development efforts by influencing the design and iteration of next‑generation systems and components for IHFM.Lead cross‑functional teams and external suppliers in the design, development, and testing of complex interventional catheter delivery systems for implantable devices.Oversee and drive timelines for feasibility studies, design verification testing, clinical evaluations, and supplier validation activities required for commercial release.Perform other duties and responsibilities as assigned.What you'll need (Required):Bachelor's degree in engineering or scientific, with 6 years of experience in new product development, process development, commercialization, and/or operations engineering in a highly regulated environment.Travel up to 25% domestically and internationally.On-site work required.What else we look for (Preferred):Master’s degree in engineering and/or MBA.Certification or formal training in Lean Six Sigma.Strong background in sensor based medical device development, with hands-on experience in design optimization and advancing innovative technologies from concept through commercialization.Hands-on experience with electronic manufacturing processes.Experience working within ISO 1348 -compliant quality systems and applying risk management principles throughout product development and commercialization.Background in at least two of the following areas: interventional access devices, rapid product development, component-level manufacturing, or complex assembly design.Demonstrated capability to apply sound engineering judgment and technical expertise to solve complex problems; working knowledge of DFM, GD&T, and Six Sigma methodologies.Proven ability to manage and collaborate with external vendors to meet quality, timeline, and technical requirements.Strong experience in rapid product development within cross‑functional teams, including creative design iteration, prototyping, and test method development (e.g., in‑vitro testing).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.