Edwards Lifesciences Staff R&D Engineer - Transcatheter Mitral and Tricuspid Therapies in Irvine, California
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 complex 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 components for the Delivery System.
Drive design selection based on clinical impact, material, and supplier manufacturability. Ability to advise and drive novel products through clinical trials and commercial readiness.
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 complex design control documents including requirement specs, and risk documents with robust knowledge on design control requirements.
Develop project plans to assess technology and drive project results.
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).
Education and Experience:
Bachelor's Degree in in Engineering or Scientific field , minimum of 6 years experience of experience, including either industry or industry/education Required or
Master's Degree or equivalent in in Engineering or Scientific field , minimum of 5 years experience of experience, including either industry or industry/education Required or
Ph.D. or equivalent in in Engineering or Scientific field , minimum of 2 years experience of experience, including either industry or industry/education Required
Required skills and experience include:
Must have demonstrated strong skills as an innovator and problem solver
Hands-on experience with catheter design and the proven ability to apply technical knowledge and judgment to complex mechanical problems in medical device design
Experience in catheter design (extrusions, braiding, molding, and bonding processes) is required
Experience with machined components is strongly preferred
Experience with tube drawing and laser cutting/welding is strongly preferred
Experience in new product development with successful design from concept to commercialization is strongly 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 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.