Edwards Lifesciences Veterans Jobs

Job Information

Edwards Lifesciences Staff R&D Engineer, Catheter Design - Transcatheter Mitral & Tricuspid Therapies in Irvine, California

This is a unique opportunity to join an early-stage development team that provides solutions to patients suffering from mitral and tricuspid valve disease. The position is on a fast-paced, early product development team in the Transcatheter Mitral and Tricuspid Therapies organization.

The individual who fills it will play a pivotal role in the design, development and testing of a transfemoral delivery system from concept to early clinical feasibility and commercialization.

Responsibilities:

  • Provide technical team leadership in the areas of product design. This includes generation and optimization of complex high strength catheter mechanisms and innovative experiments to verify design functionality.

  • Ability to analyze complex test 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 complex mechanisms and 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 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 designs.

  • 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 & Experience:

  • Bachelors Degree in Engineering

  • 6+ years experience in medical device

-4+ years of creative design expertise using Creo/ProE or Solidworks (Solidworks preferred)

  • Experience in catheter design (extrusions, braiding, molding, and bonding processes)

Preferred Education & Experience:

-Degree in Mechanical or Biomedical engineering

  • Experience with machined components

  • Experience with tube drawing and laser cutting/welding

  • Experience in new product development with successful design from concept to commercialization

Other Skills Required:

  • 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

  • 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.

DirectEmployers