Bachelor's Degree with 5+ years of clinical experience in intra-operative procedures (RN, RT, ORT, RCIS) or equivalent
Ability to travel up to 75%
Certification in RDCS (ARDMS) preferred
Experience in interventional cardiology or cardiothoracic surgery is a plus
Moderate understanding of medical device regulatory requirements
Responsibilities
Provide on-site, real-time guidance during clinical trial implants
Educate on device handling, implantation, and troubleshooting techniques
Document procedural case observations for post-procedural insights
Develop and improve training curriculum and materials based on clinical trial experience
Conduct training sessions for physicians and hospital staff on investigational products
Track clinical trial device inventory and manage shipments according to guidelines
Collaborate with product development teams for feedback on device iterations
Benefits
Competitive salaries and performance-based incentives
Wide variety of benefits programs for employees and families
Full Job Description
You will make an impact by:
Pre-Procedural, Intra-Procedural, Post-Procedural Case Support
Represent the Clinical Affairs Research Team during clinical trial cases with investigating physicians, hospital staff and clinical research coordinators by providing on-site, real-time guidance during clinical trial implants, including contingency planning to address unforeseen occurrences in support of assigned clinical investigations
Provide education on all aspects of the device, device handling, implantation and troubleshooting techniques related to equipment, tools and products required for device implants
Document procedural case observations for insights in investigating post procedural events
Education Support
Develop and continuously improve training curriculum, training materials and training tools, based on clinical trial experience
Educate and train physicians, hospital personnel and hospital staff on technical matters related to investigational products and procedures through conducting and/or coordinating one-on-one ad hoc training sessions and in-service structured education programs
Throughout clinical investigations, provide physicians and medical staff with required follow-up support to ensure continuity of education and technical support related to all aspects of clinical research
Assist in Clinical Monitoring activities
Ensure device accountability by tracking the location of all clinical trial devices. Manage inventory to include par levels, expiration dates, and initiate shipments and returns of investigational products according to regulatory and company guidelines
Collaborate with product development teams to provide feedback on device iterations and new device development
What you will need (Required):
Bachelor's Degree and a minimum of 5 years clinician experience in intra-operative procedures acquired from Registered Nursing Degree curriculum (RN), or in positions such as Radiologic Technologist (RT), Operating Room Technician (ORT), or Cardiovascular Technician (RCIS) or related medical device, clinical, or Certification in RDCS (Registered Diagnostic Cardiac Sonographer) within ARDMS (American Registry for Diagnostic Medical Sonography) OR equivalent experience based on Edwards criteria
Ability to travel up to 75%
What else we look for (Preferred):
Experience in interventional cardiology, cardiothoracic surgery, hemodynamic monitoring technology
Previous TAVR experience
Knowledge and understanding of cardiovascular science
Moderate understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
The base pay range for this position is $134,000 to $190,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
About Edwards Lifesciences Corp
Edwards Lifesciences is an American medical technology company headquartered in Irvine, California, specializing in artificial heart valves and hemodynamic monitoring. It developed the SAPIEN transcatheter aortic heart valve made of cow tissue within a balloon-expandable, cobalt-chromium frame, deployed via catheter. The company has manufacturing facilities at the Irvine headquarters, as well as in Draper, Utah; Costa Rica; the Dominican Republic; Puerto Rico; and Singapore; and is building a new facility due to be completed in 2021 in Limerick, Ireland.
