Edwards Lifesciences Staff Engineer – Transcatheter Heart Valves in Irvine, California
This is a unique and fantastic opportunity to join an innovative and challenging project within Transcatheter Heart Valve Therapies of Edwards Lifesciences. The Staff Engineer will be a key contributor to lead the development and commercialization activities of a next generation implantable devices and mentoring of engineers. They will join a highly motivated team that is used to developing innovative solutions to treating heart disease in a fast-paced environment. Job Functions:
Conceptualize, design and develop implantable devices. This includes
Developing design requirements, generating design concepts, creating prototype builds, supporting pre-clinical and clinical studies, and designing for manufacturability.
Create CAD models using Solidworks and/or Pro-E.
Drive design selection based on clinical impact, material, manufacturability, and compliance with internal and policies and procedures (QSR, FDA Regulations, and ISO Standards).
Develop, validate, and perform test methods and procedures supporting product development.
Manage and mentor junior engineers on technical development and expertise.
Establish a strong knowledge and understanding of cardiovascular anatomy, structure of the heart, and valve diseases.
Work closely with clinical, engineering, and physician partners in both a pre-clinical and clinical environment.
Work closely with project team members, internal partners, and suppliers to deliver project objectives.
Bachelor degree in Mechanical Engineering discipline is required; advanced Mechanical degree of MS or PhD is a plus
Minimum of 6+ years of experience is required in medical device including:
Creative design expertise using Creo/ProE or SolidWorks required.
Experienced designer in medical devices is must. Heart valve development from concept to commercialization is highly preferred.
Knowledge in test requirements for regulatory submission.
Knowledge in metals and fabrications.
Demonstration of strong skills as an innovator and problem solver.
Experience with rapid product development in cross-functional teams, creative design, prototyping, and test method development (in-vitro and in-vivo).
Experienced in documentation and execution such as protocol, procedures, data analysis and reports.
Must possess excellent communication, listening, collaboration and influencing skills.
High energy self-starter.
Ability 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.