This is a unique and fantastic opportunity to join an innovative and challenging project within Transcatheter Mitral and

Tricuspid Therapies of Edwards Lifesciences. The Principal Engineer will be a key contributor to lead the development

and commercialization activities of a next generation catheter system and mentoring of engineers. They will join a highly

motivated team that is used to developing innovative solutions to treating heart disease in a fast-paced environment.

**Responsibilities:**

+ Conceptualize, design and develop complex, interventional catheters for delivery of implantable devices. This includes

+ developing design requirements, generating design concepts, creating prototype builds, supporting pre-clinical and clinical

+ studies, and designing for manufacturability

+ Create CAD models and detailed drawings for delivery system

+ Drive design selection based on clinical impact, material, manufacturability, and compliance with internal and policies and

+ procedures (QSR, FDA Regulations, and ISO Standards)

+ Develop, validate, and perform test methods and procedures supporting product development

+ Drive design verification and validation testing

+ Generate test protocols, reports, and supporting documentation for feasibility and design verification/validation tests

+ Manage and mentor junior engineers on technical development and expertise

+ Establish a strong knowledge and understanding of cardiovascular anatomy, structure of the heart, and valve diseases

+ Work closely with clinical, engineering, and physician partners in both a pre-clinical and clinical environment

+ Work closely with project team members, internal partners, and suppliers to deliver project objectives

#LI-BV1

#MI

Qualifications:

**Qualifications:**

+ Bachelor’s degree in engineering; mechanical or biomedical is preferred

+ A minimum of 8 years of experience in the medical device R&D developing devices from concept to commercialization required

+ Class III medical device R&D experience required

+ 5 years of creative design expertise using Creo/ProE or SolidWorks required.

+ Mechanical design and delivery system catheter design experience (extrusions, braiding, molding, and bonding

+ processes) required

+ Managing junior engineers and technicians preferred

+ Knowledge of cardiovascular system anatomy

+ Strong communication skills with vendors, cross-functional team members, vendors, and physicians.

+ Strong technical writing skills to report out technical data to internal stakeholders and regulatory agencies

+ Proven ability to apply technical knowledge and judgment to complex engineering problems

+ Demonstration of strong skills as an innovator and problem solver

+ Experience with rapid product development in cross-functional teams, creative design, prototyping, and test method

+ development (in-vitro and in-vivo)

+ Preferred background includes experience in more than one of the following areas: Interventional access devices, rapid

+ product development, and mechanical component design

+ High energy self-starter

+ Ability to achieve results with minimal direction

About Edwards

Edwards Lifesciences is the
global leader in patient-focused medical innovations for structural heart
disease, as well as critical care and surgical monitoring. Driven by a passion
to help patients, the company collaborates with the world’s leading clinicians
and researchers to address unmet healthcare needs, working to improve patient
outcomes and enhance lives. Headquartered in Irvine, California, Edwards
Lifesciences has extensive operations in North America, Europe, Japan, Latin
America and Asia and currently employs over 13,000 individuals worldwide.

For
us, helping patients is not a slogan – it’s our life’s work. From developing
devices that replace or repair a diseased heart valve to creating new
technologies that monitor vital signs in the critical care setting, we focus on
helping patients regain and improve the quality of their life. Edwards is an Equal
Opportunity/Affirmative Action employer including protected Veterans and
individuals with disabilities.

Title: Principal Engineer, R&D – Transcatheter Mitral and Tricuspid Therapies
Location: USA-USA-California – Irvine
Job Number: 020267

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