This is a unique and fantastic opportunity to join Edwards Lifesciences in the Advanced Technologies Division on an early stage technical project. This opportunity will be on a fast paced program in the early stages of development, as it defines the device design and prepares for clinical implementation. The Manager will be a key contributor to the design of the implant and management of junior engineers.
**Key responsibilities include:**
+ Design and develop an implantable device. This includes developing design requirements, generating design concepts, creating prototype builds, pre-clinical evaluations, supporting clinical studies, and design for transfer to manufacturing.
+ Manage and mentor junior engineers on technical development and expertise.
+ Work closely with clinical, engineering, and physician partners in both a pre-clinical and clinical environment with strong knowledge and understanding of cardiovascular anatomy, structure of the heart, and valve diseases.
+ Drive design selection based on clinical impact, material, and supplier manufacturability. Develop test methods and procedures to evaluate device prototype performances.
+ Interface with Manufacturing, Clinical Affairs, Quality, Marketing, outside consultants, and vendors/suppliers, to ensure compliance with internal and policies and procedures (QSR, FDA Regulations, and ISO Standards).
The ideal candidate requires a Bachelor’s degree in engineering; mechanical or biomedical is preferred and a minimum 8 years of experience in the medical device industry OR a master’s degree in engineering or materials in combination with 6 years of medical device experience.
**Required skills and experience include:**
+ Must be able to demonstrate strong skills as an innovator and problem solver
+ Experience developing interventional class III implantable medical devices (510K/PMA Products) is required.
+ Medical Device experience in new product development with successful design from concept to FIH is required. This includes experience with medical device materials.
+ Experience managing junior engineers preferred
+ A minimum of four years of creative design expertise using Solidworks or CREO is required
+ Clinical and anatomical knowledge with an ability to communicate with collaborating physicians is preferred.
+ Proven ability to apply technical knowledge and judgment to complex engineering problems.
+ Must be able to demonstrate strong skills as an innovator and problem solver, as well as a mentor to junior engineers.
+ Experience with rapid product development in cross-functional teams, creative design, prototyping, and test method development (in-vitro and in-vivo).
+ Strong problem solving skillset and the ability to rapidly iterate and react to clinical device feedback.
+ Preferred background includes experience in more than one of the following areas: Nitinol implantable devices, rapid product development, and Mechanical component design.
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 10,000 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. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.
Title: Manager, R&D Engineering – BioDesign -Implants -Advanced Technology
Location: USA-USA-California – Irvine
Job Number: 016115