Edwards Lifesciences Staff R&D Engineer - Transcatheter Mitral & Tricuspid Therapies in Irvine, California
This is an exciting opportunity for an exceptional engineering professional with advanced catheter experience to join a team that is boldly designing transcatheter mitral and tricuspid therapies (TMTT) 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 Irvine-based R&D Staff Engineer role is an opportunity to join a fast-paced and passionately patient-focused team as a technical leader in the design and development of transcatheter mitral valve replacement delivery system and accessories, from concept selection to early human use to pivotal trial readiness. A strong candidate will be a hands-on engineer with an ability to think both creatively and with a solutions mindset, have self-starter confidence, and an internal drive to solve challenging engineering problems. This position will report into a Sr. Manager of R&D for Transcatheter Mitral Valve Replacement (TMVR) delivery systems.
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.
Lead the conceptualization, design, evaluation, and construction of complex delivery devices by generating design requirements, brainstorming, evaluating design concepts, demonstrating proof-of-concept and feasibility, managing vendors and suppliers, supporting design verification and validation, developing robust processes, engaging in pre-clinical evaluations, supporting clinical studies, and transferring to manufacturing.
Develop elegant technical solutions by owning complex problems which require a strong mechanical aptitude and creativity
Maintain accurate documentation of concepts, designs, drawings, and procedures as well as generate written protocols, reports, and technical justifications/summaries.
Present relevant results and findings to the team, management, cross-functions, and partnering physicians.
Design of novel catheter components and complex subassemblies with 3D Modeling
Develop new test methods, design and procurement of tooling, and equipment, under the direction of project leader.
Translate early stage clinical learnings and feedback into design related improvements for future development and innovation.
Create, test, and/or improve products by developing moderately complex experiments and tests (including writing and executing protocols), analyzing results, making recommendations, and writing reports, based on engineering principles.
Partner with Manufacturing and Quality to develop work instructions, routers, in-process inspections and quality inspections
Collaborate with technicians; providing training or instructions for build and/or test execution.
Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers.
Leverage expertise in aligning a cross functional team in making meaningful and significant decisions
Provide technical mentorship to junior level engineers.
Education and Experience:
Bachelor's degree + 6 or more years of experience OR Master's degree + 4 or more years of experience
Experience must be in medical device industry developing catheter technologies
Preferred Degree will be in Mechanical or Biomedical Engineering
Technical depth in catheter design and processes (extrusions, braiding, coiling, molding, reflow, and bonding processes) is required.
Expertise in using 3D Modeling software is required. Solidworks is preferred.
Strong test method development and verification and validation is strongly preferred
Must be able to demonstrate creative thinking, attention to detail, and produce unique solutions to solve problems.
Experience with Design Controls and Risk Management within a product development setting is required.
Hands-on approach required with a willingness to prototype and build new designs.
Effective communication, listening, and diagnostics skills, both verbal and written, are required. The ability to collaborate and influence will be key towards achieve resolution within the team and with cross functional stakeholders.
Willingness to challenge norms and persevere through design learnings.
Demonstrates a sense of urgency; understands the importance of outperforming and outpacing the competition in meeting customer and patient needs.
Experience with machined components is required.
Experience with tube drawing, laser cutting, and laser welding processes is preferred.
Strong mechanical aptitude and experience in assembly processes is required.
Prior experience with image measurement and analysis or programming tools to help facilitate characterization is desired.
Experience in statistical analysis or Six Sigma Black Belt Certification desired.
Previous experience working with lab/industrial equipment desired.
Strong documentation and organization skills preferred
Ability to build productive and professional internal/external working relationships (i.e. vendors and project stakeholders).
Ability to work well independently and as a member of a team is essential.
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.