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Irvine, California - USD Full Time Posted: Monday, 19 June 2017
 
 
Join a premier engineering team working at the forefront of new and innovative technologies which directly save lives. 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.

Edwards Lifesciences is currently seeking a Product Development Engineer to develop and design novel medical devices for our Transcatheter Heart Valve Business Unit at our corporate headquarters in Irvine, CA.

Primary responsibilities include:

. Generate catheter design concepts & improvements, 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 performance.

. Conduct tests utilizing existing test protocols, or develop new ones as needed and generate related written reports.

. 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 temporary workers 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 complex problems, but independently determines and develops approaches to solutions

Qualifications

The Staff Engineer requires a minimum of six years of relevant engineering experience to include exposure to design of experiments, design control systems, specification development, and prototyping. Experience in the medical device industry with emphasis on less invasive surgical procedures is a must.

. BS in Engineering is required, advanced degree a plus

. Catheter experience, design, manufacturing, and process development

. Knowledge and experience with catheter product development from design to product launch, implants a plus.

. Knowledge of device Design Control, Quality Systems, documentation

. Good communication skills, written and verbal

. Experience working in cross functional teams and independent contributor role

. Experience developing test plans, and in-vitro/in-vivo testing

. Experience with CAD and/or solid modeling a plus in programs such as Pro-E, Solidworks

. Experience with extrusions, materials, braided shafts, articulating designs, varied French sizes, etc.

. Experience with nitinol, cobalt chromium, and stainless steel materials a plus

Posted by StartWire



Irvine, California, United States of America
Engineering
USD
Edwards Lifesciences Corp
Edwards Lifesciences Corp
JS2124_4FE37759071799095CA4D44AC4E7A049_228_I/228123022
6/19/2017 5:57:09 AM

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