Edwards Lifesciences Principal Engineer - R&D (Implant) 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 heart failure.
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 in Engineering or Scientific field and 8+ years of experience - OR -
Master's Degree in Engineering or Scientific field and 7+ years of experience - OR -
Ph.D. in Engineering or Scientific field and 4+ years of experience
Experience in metals, particularly Nitinol, and mechanical design required (stent and/or implantable medical device) 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, physiology, and heart failure pathology.
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.