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This is a unique opportunity to play a critical role in the growth of new cutting-edge heart valve therapies for Transcatheter Mitral and Tricuspid Therapies (TMTT).As a Clinical Education Imaging Specialist within TMTT, you will work closely with global KOLs and the Edwards' Clinical Research Teams across several exciting therapeutic devices. You will have direct impact to procedural development of our technologies as we bring early-stage technologies through Clinical Trials and towards commercial markets.This role is a key clinical support role that will require learning current TMTT devices, providing procedural guidance to clinicians in the clinical study setting with good understanding of image-based navigation, supporting physician training for new and existing clinical trial sites, and providing input on evolving aspects of the product development process.Key Responsibilities including but not limited to :PROCEDURE SUPPORT
Represent the TMTT Team during clinical trial cases with investigating physicians, and hospital staff by providing on-site, real-time guidance during clinical trial implants or cases, including contingency planning to address unforeseen occurrences in support of assigned clinical investigations
Provide education and training on device components, functionality, procedural steps, troubleshooting techniques related to device required for patient and device preparation
Provide all necessary information required during the case and report summaries on case observations to Clinical Safety
Review and provide guidance to physicians on procedural planning (e.g., sizing, patient anatomy)
Collaborate with team to review and approve patients prior to procedure
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
RESEARCH SUPPORT
Interface with investigation and clinical research staff to manage logistics associated with investigational meeting attendance, and protocol and device training
Collaborate with product development teams to provide feedback on device iterations and new device development
Assist in Clinical Monitoring activities
Provide logistics assistance for pre and post procedures
Required Qualifications:Bachelor's Degree and a minimum of 3 years of relevant medical device and/or procedural clinical imaging experience (using interventional echo-navigation with 2D/3D TEE) OR
RN degree with a minimum of 5 years of relevant medical device and/or procedural clinical imaging experience (using interventional echo-navigation with 2D/3D TEE) OR
Other Certification: in RDCS (Registered Diagnostic Cardiac Sonographer) within ARSMS (American Registry for Diagnostic Medical Sonography) or equivalent certification a minimum of 7 years of relevant medical device and/or procedural clinical imaging experience (using interventional echo-navigation with 2D/3D TEE)
Ability to travel up to 75%
Preferred Qualifications:Previous experience in guiding physicians or proctoring cases
Experience with supporting cases relating to mitral or tricuspid valves
General Expectations:Proficient in MS Office Suite and ability to operate general office machinery
Good written and verbal communication skills, presentation, and interpersonal relationship skills including negotiating and relationship management skills
Good problem-solving and critical thinking skills
Moderate knowledge and understanding of cardiovascular science
Moderate understanding of cardiovascular anatomy, pathology and physiology
Moderate understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting
Ability to manage confidential information with discretion
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
Ability to build productive internal/external working relationships
Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.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.
Full-time- ID: #22196348
- State: Minnesota Minneapolis / st paul 55401 Minneapolis / st paul USA
- City: Minneapolis / st paul
- Salary: USD TBD TBD
- Showed: 2021-11-04
- Deadline: 2022-01-03
- Category: Et cetera