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Staff R&D Stent Engineer - Transcatheter Heart Valve

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

Job Description:

The Staff R&D Stent Engineer position is a unique and rewarding opportunity to grow the Edwards Lifesciences Transcatheter Pulmonic Valve Program for the treatment of congenital heart valve disease. The position is part of a fast-paced development team, and will play a key role in the design, development and testing of a transcatheter stent. Key responsibilities include: Technical Leadership Brainstorm, assess and design to bring an idea to new product development Apply mechanical and biomedical engineering principals to the design and development of devices Drive design selection based on clinical impact, material, and supplier manufacturability Develop test methods and procedures to evaluate device prototype performances Maintain accurate documentation of concepts, designs, drawings, and procedures - generate written protocols, reports, and technical justifications/summaries Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company products and therapies Work closely with 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 to enhance technology currently in development as well as identify new opportunities for novel devices to address unmet clinical need Present relevant results and findings to team, management, and partnering physicians 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) Required qualifications: Bachelor's degree in engineering; mechanical or biomedical engineering is strongly preferred 6 years of experience in the medical device industry 4 years of creative design expertise using ProE or Solidworks (experience with Solidworks is highly preferred) Preferred Qualifications: A Master's degree in engineering or materials may lessen some of the experience requirements Experience in stent design and a working knowledge of FEA is strongly preferred Experience in new product development with successful design from concept to commercialization is strongly preferred Experience with nitinol stents is preferred. Should have demonstrated strong skills as an innovator and problem solver Hands-on experience and proven ability to apply technical and clinical knowledge and judgment to solve technical problems Technical proficiency specific to mechanical problem solving in medical device design Experience in new product development with successful design from concept to commercialization is strongly preferred Effective communication, listening, and diagnostic skills, verbal and written, are necessary - the demonstration of effective collaboration and influencing skills will be the key to achieving results within the cross-functional team and with stakeholders around the company Ability to work well independently and as a member of a team is essential Should be comfortable interacting with leading cardiologists and surgeons as well as taking an active role in animal studies and investigations Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Keywords: Edwards Lifesciences, Irvine , Staff R&D Stent Engineer - Transcatheter Heart Valve, Other , Irvine, California

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