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Senior Principal Engineer, R&D, Delivery Systems
Job in
Irvine, Orange County, California, 92604, USA
Listed on 2026-07-02
Listing for:
Edwards Lifesciences
Full Time
position Listed on 2026-07-02
Job specializations:
-
Engineering
Biomedical Engineer, Systems Engineer, Product Engineer
Job Description & How to Apply Below
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
** How you will make an impact:*
* We are seeking a Senior Principal Delivery System Engineer to play a key role on the next generation EVOQUE transcatheter tricuspid valve replacement team. In this role, you will serve as a lumen and subsystem owner, responsible for advancing critical catheter subassemblies from early concept through design freeze and into later phases supporting commercial launch. You will collaborate closely with a dedicated team of R&D engineers and cross-functional partners to bring the next generation EVOQUE platform to market;
contributing directly to a transformative therapy aimed at improving outcomes for patients with tricuspid valve disease.
+ Contribute to the development of a next‑generation transcatheter tricuspid valve replacement system by applying clinical insights and learnings from previous device generations to advance the design and address unmet patient and user needs.
+ Initiate and lead in the improvement, design and optimization of highly complex tests, analyze results, provide complex recommendations, and develop reports, based on engineering principles that translate to innovative products
+ Lead concept development and prototype iteration internally and with external vendors, applying data‑driven evaluation and clearly communicating findings and recommendations.
+ Own and manage the design and budget of catheter and lumen subsystems from concept selection through design freeze and into verification and validation.
+ Proactively identify issues, achieve resolution, and resolve problems of highly significant complexity on designing parts, components and subsystems by balancing mechanical performance targets (e.g., tensile strength, flexibility, profile) with clinical performance needs (e.g., echogenicity, stability) and manufacturability requirements.
+ Work closely with cross‑functional teams in pre‑clinical and clinical environments to guide design decisions informed by cardiovascular anatomy, heart structure, and valve pathology.
+ Generate work instructions, IP, engineering models, and drawings; coordinate prototype builds; and develop project plans to establish/characterize product and/or process specifications and assess complex technology.
+ Maintain accurate documentation of concepts, designs, drawings, and procedures.
+ May lead cross functional teams through complex design control activities including requirement specs, and risk documents with substantial knowledge on design control requirements
+ Oversee R&D support activities; coordinate technician/engineer work; provide direction on prototyping and testing; and train technicians/engineers while providing constructive feedback.
+ Interface with Clinical Development, Manufacturing, Quality, Marketing, and vendors/suppliers to ensure compliance with internal policies and procedures, FDA regulations, and ISO standards.
+ Provide direction and guidance on strategies related to technical solution areas
** What you'll need (Required):*
* + Bachelor's Degree in Engineering or Scientific field with a minimum of 8 years of experience **-OR
- ** Master's Degree or equivalent in Engineering or Scientific field with a minimum of 7 years of experience **-OR
- ** Ph.D. or equivalent in Engineering or Scientific field with a minimum of 4 years of…
Position Requirements
10+ Years
work experience
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