Edwards Lifesciences Staff R&D Engineer - Advanced Technology in Irvine, California
This is a unique opportunity to join an early-stage development team that provides solutions to patients suffering from structural heart disease. The position is on a fast-paced, early product development team in the Advanced Technologies organization. The individual who fills it will play a pivotal role in the design, development and testing of a kit of catheters and sheaths from concept to early clinical feasibility and commercialization.
Provide technical team leadership in the areas of product design and experimentation. This includes generation and optimization of complex experiments as well as the ability to analyze results, provide recommendations, and develop reports, based on engineering principles that translate to innovative products.
Apply mechanical and biomedical engineering principals to the design and development of catheters.
Drive design selection based on clinical impact, material, and supplier manufacturability.
Proactively identify issues, achieve resolution, and resolve problems of significant complexity on designing parts, components and subsystems.
Generate work instructions, test methods, engineering models and drawings/prototypes, etc., to establish/characterize product and/or process specifications.
Maintain accurate documentation of concepts, designs, drawings, and procedures. Generate written protocols, reports, and technical justifications/summaries.
Create/update design control documents including requirement specs, and risk documents with robust knowledge on design control requirements.
Oversee R&D support tasks; give instruction to technicians/engineers on conducting tests; train technicians/engineers and provide feedback; and coordinate technician/engineer work.
Train, coach, and guide lower-level employees on more complex procedures.
Work closely with 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.
Work with clinicians to understand market needs, gather relevant feedback for concepts and procedural methods, and perform bench-top and animal testing.
Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company products and therapies.
Present relevant results and findings to team, management, and partnering physicians.
Interface with Manufacturing, Clinical Affairs, Quality, Marketing, vendors/suppliers, to ensure compliance with internal and policies and procedures (QSR, FDA Regulations, and ISO Standards).
Required Education and Experience:
-Bachelor's Degree + 5 or more years of experience
Master's Degree + 3 or more years of experience
Ph.D + 1 or more years of experience
-Medical Device Experience
Other required skills include:
Must have demonstrated strong skills as an innovator and problem solver
Hands-on experience with catheter design (preferably EP and CRT) and the proven ability to apply technical knowledge and judgment to complex mechanical problems in medical device design
Experience in catheter design (extrusions, braiding, tip forming, and bonding processes) is preferred
Experience with machined components is preferred
Experience with tube drawing and laser cutting/welding is preferred
Experience in new product development with successful design from concept to commercialization is preferred
Effective communication, listening, and diagnostic skills, verbal and written, are necessary. The demonstration of effective collaboration and influencing skills will be key so that the candidate can achieve results within the cross functional team and with stakeholders around the company
Ability to work well independently and as a member of a team is essential
Self-starter with high levels of accountability
The candidate must also be comfortable interacting with leading cardiologists and surgeons as well as taking an active role in animal studies and investigations
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.