Edwards Lifesciences: 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 ofcomplaints 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 RequiredAdditional 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 skillsEdwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

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