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R&D Senior Engineer - Transcatheter Mitral and Tricuspid Therapies

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

Job Description:

Key Responsibilities: --- Lead and drive changes required for the commercial PASCAL implant --- Train, coach, and guide lower level employees on standard engineering practices --- Work with the complaints team to provide R&D review and analysis of complaints --- Provide R&D support for transfer of device manufacturing to commercial production lines --- Develop and execute engineering project plans --- Write protocols, reports, and technical summaries --- Execute and support design verification testing --- Identify, evaluate, manage, and provide guidance to suppliers --- Define acceptance criteria for suppliers and establishing tolerances and specification --- Work in both a pre-clinical and clinical environment to evaluate technology --- Gain intimate understanding of cardiovascular anatomy and structure heart and valve diseases --- Interface with Manufacturing, Clinical Affairs, Quality, Marketing, outside consultants, and vendors/suppliers, to ensure compliance with internal and external policies and procedures (QSR, FDA Regulations, and ISO Standards). Education and Experience: --- Bachelor's Degree in Engineering or Scientific field, 4 years years experience Required or --- Master's Degree or equivalent in Engineering or Scientific field, 3 years years experience Required or --- Ph.D. or equivalent in Engineering or Scientific field Required Additional Skills: --- Effective communication, listening, and diagnostic skills, verbal and written, are necessary; the demonstration of effective collaboration and influencing skills will be key so that the candidate can achieve results within the cross functional team and with stakeholders around the company --- Proficiency in the usage of relevant computer software --- Strong documentation and communication skills --- Strong interpersonal relationship skills including negotiating/relationship management skills --- Ability to manage competing priorities in a fast-paced environment --- Ability to work well independently and as a member of a team is essential --- Ability to interact professionally with all organizational levels --- The candidate must also be comfortable interacting with leading cardiologists and surgeons --- Ability to apply technical knowledge and judgment to complex engineering problems --- Experience with nitinol-based implants is strongly preferred --- Experience in a commercial environment is strongly preferred --- Basic understanding of statistical techniques --- Strong problem-solving, organizational, analytical and critical thinking skills Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

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

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