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USA - California – Irvine, United States of America
Onsite
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.
Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. 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 and Catalyst processes 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, and ISO standards.
Support and contribute to product development efforts by influencing the design and iteration of next‑generation delivery systems and components for Surgical Therapies.
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 we look for:
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 medical device industry.
Travel up to 25% domestically and internationally.
On-site work required.
What else we look for:
Master’s degree in engineering and/or MBA.
Experience in medical device new product development, including successful design optimization and progression from early development through commercialization.
Background in at least two of the following areas: interventional access devices, rapid product development, component-level manufacturing, or complex assembly design.
Hands-on experience with catheter manufacturing processes, such as extrusions, braiding, molding, laser welding, and bonding techniques.
Demonstrated capability to apply sound engineering judgment and technical expertise to solve complex problems; working knowledge of DFM, GD&T, and Six Sigma methodologies.
Technical skills in biomedical design and delivery system catheter design.
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, the base pay range for this position is $121,000 - $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.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.