Senior Clinical Development Specialist - Transcatheter Valve

Edwards Lifesciences Gruppe; United States; On-site; USD 134,000 - 190,000; Full time

Job summary

Edwards Lifesciences is seeking a Senior Specialist, Clinical Development to act as a subject matter expert supporting transcatheter therapies. The role requires hands-on clinical engagement, procedural innovation, and continuous learning on site in Irvine, CA, with travel nationwide up to 50%.

You will represent the TMTT unit in complex cases, document observations, support enrollment discussions, and develop materials and education on device handling and techniques.

Qualifications

• Bachelor's Degree in Engineering or Scientific field, with 4 years experience including either industry or industry/education.
• Master's Degree or equivalent in Engineering or Scientific field, with 3 years experience including either industry or industry/education.
• Tricuspid or Mitral procedural experience within OR Cath Lab as Proctor or Industry Case Support.
• Demonstrated experience in customer-facing roles, including direct engagement with physicians and leading training and procedures.
• Substantial knowledge and understanding of principles, theories, and concepts relevant to Engineering and cardiovascular science.

Responsibilities

• Represent TMTT during complex research cases with investigating physicians, hospital staff and clinical research coordinators by providing on-site, real-time guidance during implants.
• Document procedural case observations for insights in investigating post-procedural events.
• Support enrollment discussions and assistance with issue escalation with Principal Investigator and research team.
• Develop materials and provide education on all aspects of the device, device handling, implantation and troubleshooting techniques.
• Develop, analyze, and optimize the design of complex procedures, testing, and therapies leveraging substantial understanding of clinical imaging.
• Coordinate all clinical imaging training and instruction for cross-functional teams as products move from ESAPCU to early human use to the commercial setting.
• Create complex design control and trial-related documentation and support all complaint and investigational analyses supporting the therapy.
• Make recommendations for improvements.

Skills

Clinical development

SME experience

Engineering degree

Education

Bachelor's degree in Engineering or Scientific field

Master's degree or equivalent

Job description

Edwards Lifesciences is seeking a Senior Specialist, Clinical Development to act as a subject matter expert supporting transcatheter therapies. The role requires hands-on clinical engagement, procedural innovation, and continuous learning on site in Irvine, CA, with travel nationwide up to 50%.

You will represent the TMTT unit in complex cases, document observations, support enrollment discussions, and develop materials and education on device handling and techniques.