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

Company: Edwards Lifesciences
Location: Irvine
Posted on: October 15, 2020

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 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 objectivesLI-BV1 Qualifications: 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.

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

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