Edwards Lifesciences Sr. R&D Valve Engineer - Transcatheter Mitral & Tricuspid Therapies in Irvine, California
This is an exciting opportunity for an exceptional R&D Senior Engineer professional with significant experience to join a team that is boldly designing transcatheter mitral and tricuspid therapies from the ground up. TMTT is dedicated to solving the complex challenges of mitral and tricuspid disease in order to transform treatment and significantly improve patients’ lives.
This unique role will be focused on the design, development, and implementation of the next generation tricuspid valve replacement system. In this position, you will be an integral contributor to the design, evaluation, and preparation for the clinical use of future device platforms with a focus on implant design.
The time is now to join TMTT and shape mitral and tricuspid therapies that will transform treatment. Don’t miss your chance to be part of a dynamic, challenging, and rewarding environment that offers potential for growth and professional advancement for the right candidate.
Provide technical team leadership in the areas of concept ideation, product design, and experimentation. This includes idea generation and optimization of concepts as well as the ability to evaluate prototypes, and effectively communicate results/recommendations.
Drive design selection based on a data driven approach with focus on clinical impact. Work closely with cross-functional teams in both a pre-clinical and clinical environment with strong knowledge and understanding of cardiovascular anatomy, structure of the heart, and valve diseases.
Proactively identify issues, achieve resolution, and independently resolve problems of significant complexity on designing parts, components and subsystems.
Generate IP, engineering models and drawings, coordinate prototype builds, and develop project plans to assess technology and drive project results.
Maintain accurate documentation of concepts, designs, drawings, and procedures. Generate written protocols, reports, and technical justifications/summaries.
Create/update complex design control documents including requirement specs, and risk documents with robust knowledge on design control requirements.
Oversee R&D support tasks; give instruction to technicians/engineers on prototyping and conducting tests; train technicians/engineers and provide feedback; and coordinate technician/engineer work.
Train, coach, and guide lower level employees on more complex procedures.
Interface with Manufacturing, Clinical Affairs, Quality, Marketing, vendors/suppliers, to ensure compliance with internal and policies and procedures (QSR, FDA Regulations, and ISO Standards).
Required Education and Experience:
-Bachelor's Degree in Engineering
-4 or more years of medical device experience required
-Hands-on experience with implant design
Preferred Education and Experience:
- Experience with heart valve development is strongly preferred
-Mechanical or Biomedical Engineering degree preferred
Experience with FEA and Nitinol processing is preferred
Knowledge and expertise in the Biodesign process or the Design for Six Sigma methodology is desired
Must have demonstrated strong skills as an innovator, problem solver, and technical leadership
Must be highly motivated, driven, and able to tackle challenging technical problems independently with minimal supervision
Must be passionate, highly collaborative, and willing to engage in creative debate
Candidate must have a strong mechanical aptitude and flexibility to work in a dynamic work environment
Effective communication, listening, and diagnostic skills, verbal and written, are necessary. The demonstration of effective collaboration and influencing skills will be key so that the candidate can achieve results within the cross functional team and with stakeholders around the company
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 15,000 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.