Edwards Lifesciences Staff Engineer, R&D - Transcatheter Mitral and Tricuspid Therapies in Irvine, California
This is an exciting opportunity to join Edwards Lifesciences’ TMTT business unit to work with a dedicated team focused on the development and expansion of our new transcatheter mitral valve repair system. In this role, the Staff Engineer will be working on the implant team to develop, qualify, and commercialize the device. This is a position and has potential career growth opportunities working side by side with leading experts in this field.
Manage and execute in-vitro and in-vivo protocols/reports for the testing of class III cardiovascular implants per associated ISO and FDA standards.
Development of in-vitro test systems and simulations that apply to human physiologic and anatomic conditions to evaluate various designs and performance characteristics.
Support the development of new test methods, procurement of tooling and equipment and executing long term testing for implants under the direction of a project leader.
Prepare test protocols and technical reports which summarize data and provide the team with insightful analysis of results from experimentation.
Testing includes, but is not limited to, in-vivo animal studies, biocompatibility testing, metal component fatigue testing, simulated physiological hydrodynamic pulsatile testing, steady-state hydraulic testing, accelerated wear/durability testing, tensile testing, and metallurgical testing.
Work closely with project team members, internal partners in the Regulatory, Quality, Manufacturing and other departments to deliver project objectives.
Manage and/or mentor junior level engineers and technical staff.
Ideal candidate requires a Bachelor's degree in engineering; mechanical or biomedical is preferred and a minimum of 6 years of experience in the medical device industry OR a master's degree in engineering in combination with 5 years of medical device experience.
Demonstrated experience developing and testing class III implantable medical devices (510K/PMA/CE Mark Products) preferred.
Well rounded experience with Nitinol material testing highly desired.
Proficiency in 3D modeling is desired: CREO, Solidworks and/or AutoCAD.
Strong mechanical aptitude, including hands-on skills with proven ability to apply technical knowledge and judgment to complex technical problems, is required.
Highly effective verbal and written communication skills are necessary.
Ability to solve technical problems as well as identify and implement practical solutions based on device requirements and project timelines.
Demonstrated project ownership and accountability for project results.
Must be a highly motivated self-starter able to achieve results with minimal direction.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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 13,000 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.