Edwards Lifesciences Principal Engineer, R&D - Transcatheter Mitral and Tricuspid Therapies in Irvine, California
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 delivery system and the development of future implant/delivery system concepts. They will join a highly motivated team developing innovative solutions to treat heart disease in a fast-paced environment.
Conceptualize, design and develop complex implants and 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 and implant components
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 through technical development
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
Bachelor's degree in engineering; mechanical or biomedical is preferred
8 years of experience in the medical device R&D developing devices from concept to commercialization
Class III medical device R&D experience preferred
5 years of creative design expertise using Creo/ProE or SolidWorks.
Mechanical design and delivery system catheter design experience (extrusions, braiding, molding, and bonding processes)
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
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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 15,000 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.