Edwards Lifesciences Principal R&D Implant Engineer, Advanced Technology in Irvine, California
Edwards Lifesciences is seeking a Principal Engineer to provide expertise in the design, optimization, testing, and manufacturing of novel Nitinol implantable medical devices that provide solutions to patients suffering from structural heart disease.
The position is on a fast-paced, early product development team in Edwards Lifesciences' Advanced Technology division. This is a high visibility and high impact career growth opportunity working on cutting edge therapy development and technology.
Initiate and lead in the design, optimization, testing, and manufacturing of implantable medical devices. This includes developing design requirements, generating design concepts and prototypes, pre-clinical evaluations, and manufacturing processes.
Oversee R&D support tasks while mentoring and guiding engineers on design, manufacturing, and experimental testing and data analysis.
Interface with and lead cross-functional teams - Manufacturing, Quality, and Regulatory - to ensure compliance with internal and regulatory policies and standards.
Work closely with clinical, engineering, and physician training partners in pre-clinical and clinical environments with strong knowledge and understanding of cardiovascular anatomy and structural heart therapy.
Proactively identify issues, achieve resolution, and resolve problems of highly significant complexity on designing and testing parts, components and subsystems
Education and Experience:
Bachelor's Degree in Engineering or Scientific field and a minimum of 8 years experience, including either industry or industry/education is required or
Master's Degree or equivalent in Engineering or Scientific field and a minimum of 7 years experience, including either industry or industry/education is required or
Ph.D. or equivalent in Engineering or Scientific field and a minimum of 4 years experience, including either industry or industry/education is required
Creative design experience is required using Creo Parametric (preferred) or Solidworks - experience designing test fixtures, manufacturing aids, and implantable medical devices.
Experience with hands-on metal (Nitinol preferred) manufacturing and processing required - e.g. fabrication, laser cut, annealing, electropolishing.
Experience communicating design and manufacturing requirements to Nitinol manufacturing preferred.
Experience with Finite Element Analysis and Fatigue/Reliability testing desirable.
Experience developing interventional class III medical devices is required.
Medical device experience in new product development with successful design from concept to First in Human is required. Experience in commercialization of implantable medical devices is highly preferred.
Must be able to demonstrate strong skills as an innovator and problem solver with an ability to rapidly iterate and react to clinical device feedback.
Excellent interpersonal relationship skills, particularly a strong history with mentoring junior engineers or leading small development teams.
Strong leadership skills and demonstrated ability of sound engineering decision making.
Preferred background in cardiovascular anatomy and physiology
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all patient-facing and in-hospitals positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who enter a hospital or healthcare facility as part of their role. If hired and your position meets this criteria, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.
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.