Staff Engineer, R & D, Transcatheter Heart Valve

Edwards Lifesciences   •  

Irvine, CA

Industry: Business Services


5 - 7 years

Posted 379 days ago

oin a premier engineering team working at the forefront of new and innovative technologies which directly save lives. Edwards Lifesciences is currently seeking a Product Development Engineer to develop and design novel based medical devices for our Transcatheter Heart Valve Business Unit at our corporate headquarters in Irvine, CA. Edwards Lifesciences is looking for a high caliber engineer to be a key player in the continued success of our cutting edge Transcatheter Heart Valve program. This is a high visibility and high impact career growth opportunity working side by side with the leading experts in the percutaneous arena.  Primary responsibilities include: 

  • Generate design concepts, prototype builds, pre-clinical evaluations, and transfer of product to manufacturing 
  • Apply Mechanical Engineering knowledge to the design and development of new products - Solve Mechanical Engineering problems at the component through system level 
  • Develop, maintain and execute R&D project plans and coordinate cross functional team developmental activities in support of company's strategic plan 
  • Develop test methods and procedures to evaluate device prototype performances 
  • Conduct tests utilizing existing test protocols, or develop new ones as needed and generate related written reports 
  • Interaction with Key Opinion Leaders (KOLs) to determine their needs/wants 
  • Maintain accurate documentation of concepts, designs, drawings, and processes 
  • Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company products 
  • Assign work to technicians and temporaryworkers as needed 
  • Interface with manufacturing, clinical affairs, quality, sales and marketing, outside consultants and vendors to ensure compliance with internal and external policies and procedures, QSR and FDA regulations and ISO standards 
  • May receive technical guidance on the most unusual or complex problems, but independently determines and develops approaches to solutions 


  • The Staff Engineer requires a bachelor's degree in Engineering and a minimum of five years of relevant engineeringexperience to include exposure to design of experiments, specification development, and prototyping. With a Master’s degree, four years of relevant experience is required.
  • Experience in the medical device or other highly regulated industry with emphasis on interventional surgical procedures is desired
  • Prior clinical experience in an interventional, vascular or cardiac surgery arena a plus
  • Must have strong track record of building and maintaining vendor relationships 
  • Must have good interpersonal skills 
  • Understand extrusion, tubing, and injection molding
  • Basic understanding of the Human Anatomy is desired 
  • Proficiency in 3D modeling is desired: Pro Engineer, Solidwords and/or AutoCAD