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Principal Engineer, R&D - Transcatheter Mitral and Tricuspid Therapies

Company: Edwards Lifesciences Corp
Location: Irvine
Posted on: May 3, 2021

Job Description:

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.Responsibilities: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 manufacturabilityCreate CAD models and detailed drawings for delivery system and implant componentsDrive 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 developmentDrive design verification and validation testingGenerate test protocols, reports, and supporting documentation for feasibility and design verification/validation testsManage and mentor junior engineers through technical developmentEstablish a strong knowledge and understanding of cardiovascular anatomy, structure of the heart, and valve diseasesWork closely with clinical, engineering, and physician partners in both a pre-clinical and clinical environmentWork closely with project team members, internal partners, and suppliers to deliver project objectivesQualifications:Bachelor's degree in engineering; mechanical or biomedical is preferred8 years of experience in the medical device R&D developing devices from concept to commercializationClass III medical device R&D experience preferred5 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 preferredKnowledge of cardiovascular system anatomyStrong 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 agenciesProven ability to apply technical knowledge and judgment to complex engineering problemsDemonstration of strong skills as an innovator and problem solverExperience 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 designHigh energy self-starterAbility to achieve results with minimal directionEdwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Keywords: Edwards Lifesciences Corp, Irvine , Principal Engineer, R&D - Transcatheter Mitral and Tricuspid Therapies, Other , Irvine, California

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