Sr. R&D Engineer - Transcatheter Heart ValveEdwards Lifesciences - Irvine, CA
Sr. R&D Engineer - Transcatheter Heart Valve
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 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 unusual or complex problems, but independently determines and develops approaches to solutions.
The Senior Engineer requires a bachelor's degree in Engineering and a minimum of four years of relevant engineering experience to include exposure to design of experiments, specification development, and prototyping.
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.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.
Title: Sr. R&D Engineer - Transcatheter Heart Valve
Location: USA-USA-California - Irvine
Job Number: 012432
Edwards Lifesciences Jobs
8 days 18 hours ago
applySr. R&D Engineer - Transcatheter Heart Valve Edwards Lifesciences - Irvine, CA, United States
Edwards Lifesciences has its heart in the right place. Named for co-inventor of the first artificial heart valve Miles "Lowell" Edwards, the company is a spinoff from Baxter International. Edwards makes instruments for cardiovascular disease patients. The company focuses on cardiac surgery products, critical care products, and vascular products. Its products include replacement valves, valve repair equipment, hemodynamic monitoring systems, catheters, surgical clips and inserts, and artificial implantable grafts. Edwards markets through a direct sales force and through distributors, of which Baxter is one. Edwards operates worldwide.
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