Edwards Lifesciences Principal R&D Engineer, Metals COE - Advanced Technology in Irvine, California
This is a unique and fantastic opportunity to join Edwards Lifesciences in the Metals Center of Excellence (COE) for the Advanced Technologies business unit. This opportunity will be supporting multiple fast-paced programs in the early stages of development, assisting teams to define the device design and usher product through clinical implementation.
The Principal Engineer will be a key contributor to the design and development of metals components, equipment, and processes. The ideal candidate is expected to lead rapid prototyping, research, and technology development efforts while providing global support for internal and external manufacturing. Responsibility may include supervising engineers and/or technicians.
Key responsibilities include:
Conceptualize, design and develop complex, components, tooling, equipment, and processes for class III implantable devices. This includes rapid prototyping, design, and development of equipment and processes for metals manufacturing, project team support, and interfacing with key external suppliers.
Work closely with project team members and internal partners to deliver the project's technical objectives.
Mentor junior engineers on technical development and expertise.
Assist design selection based on clinical impact, material, and supplier manufacturability. Assist development of test methods and procedures to evaluate prototype performance.
Interface with Manufacturing, R&D, 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, metallurgical, or biomedical is preferred.
A minimum of 8 years of experience in the medical device industry OR a master's degree in engineering or materials in combination with 7 years of medical device experience. A minimum of five years of creative design expertise using Pro Engineer is preferred.
Required skills and experience include:
Skills in mechanical design utilizing CAD is required.
Experience in metals (SS, CoCr, NiTi), and mechanical design required. Candidate must have proven experience designing components for delivery systems and/or implants.
Medical Device experience in new product development with successful design from concept to commercialization is strongly preferred. This includes experience with medical device materials.
Clinical and anatomical knowledge with an ability to communicate with collaborating R&D engineers 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 in metals manufacturing (machining, laser cutting, chemical polishing) is required.
Experience in metals analytical testing (DSC, metallography, SEM, corrosion, Auger) is preferred.
Ability to work well independently and as a member of a team is essential.
Experience with rapid product development in cross-functional teams, creative design, prototyping, and test method development.
Six Sigma Black-Belt preferred.
Strong problem-solving skillset and the ability to rapidly iterate and react to customer feedback.
Preferred background includes experience in more than one of the following areas: Nitinol manufacturing, Metallic implant manufacturing, Rapid product development, Electrochemistry, Metals 3D printing, Metals Machining, Process development, Statistics, and Mechanical component design.
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.