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Principal R&D Engineer - Transcatheter Mitral & Tricuspid Therapies

Company: Edwards Lifesciences Corp
Location: Irvine
Posted on: June 7, 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 transcatheter annuloplasty implant design and mentoring of engineers. They will join a highly motivated team that is used to a fast-paced environment.

Responsibilities:

  • Conceptualize, design and develop complex, transcatheter implantable devices. This includes developing design requirements, generating design concepts, creating prototype builds, pre-clinical evaluations, supporting clinical studies, and design for transfer to manufacturing

  • Mentor junior engineers on technical development and expertise

  • Work closely with clinical, engineering, and physician partners in both a pre-clinical and clinical environment with strong knowledge and understanding of cardiovascular anatomy, structure of the heart, and valve diseases

  • Drive design selection based on clinical impact, material, and supplier manufacturability

  • Develop test methods and procedures to evaluate device prototype performances

  • Interface with Manufacturing, Clinical Affairs, Quality, Marketing, outside consultants, and vendors/suppliers, to ensure compliance with internal and policies and procedures (QSR, FDA Regulations, and ISO Standards)

  • Drive design/process changes to prepare for commercialization readiness

  • Develop and qualify test methods and procedures

  • Generate test protocols, reports and supporting documentation for design verification

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

Required Education & Experience:

  • Bachelor's degree in engineering mechanical or biomedical is preferred

  • A minimum of 8 years of experience in the medical device industry

  • A minimum of five years of creative design expertise using Creo/ProE or SolidWorks is a must, SolidWorks is preferred

  • Experience in implant design

Other Required Skills:

  • Skills in mechanical design

  • Medical Device experience in new product development with successful design from concept to FIH

  • Experience managing junior engineers preferred

  • Clinical and anatomical knowledge with an ability to communicate with collaborating physicians is preferred

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

  • Must be able to demonstrate strong skills as an innovator and problem solver, as well as a mentor to junior engineers

  • Experience with rapid product development in cross-functional teams, creative design, prototyping, and test method development (in-vitro and in-vivo)

  • Strong problem solving skillset and the ability to rapidly iterate and react to clinical device feedback

  • 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 Corp, Irvine , Principal R&D Engineer - Transcatheter Mitral & Tricuspid Therapies, Other , Irvine, California

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