Edwards Lifesciences Sr. Clinical Imaging Specialist (Mitral - West Coast Field) in Irvine, California
This is a unique opportunity to play a critical role in the growth of new cutting-edge heart valve therapies for Mitral Valve Replacement. As a Sr. Clinical Imaging Implant Specialist within Transcatheter Heart Valve Therapies (THV), you will work closely with Global KOLs and the Edwards Clinical Research Teams across 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 THV 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.
Provide on-site, real-time image-based procedural guidance during clinical implants, including contingency planning to address unforeseen occurrences in support of assigned clinical investigations.
Gaining expertise on THV Devices, understanding the device specifications and IFUs, and supporting device prep for clinical cases.
Educate Physicians on Image-related protocols, including screening and case planning, image-guidance techniques, post-procedural assessment, and relevant imaging technologies
Educate 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 learning and training updates
Help 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 Structured Training Programs, On-site Training Updates and Refreshers, and Ad-hoc in-services at local centers and educational venues such as scientific conferences
Provide physicians and medical staff with required follow-up support to ensure continuity of education and technical support related to all aspects of device and procedural learning
Interface with investigational and clinical research staff to manage logistics associated with investigational meeting attendance, and protocol and device training.
Ensure device accountability by tracking the location of all clinical trial devices.
Help 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
Field based West Coast region
College Degree or Certification in RCIS/CVT/RTR/RDCS field required.
Minimum of Five years of relevant Industry Experience or Clinical Experience is required.
Interventional Echo-navigation Imaging experience, particularly with 2D/3D TEE imaging for screening is required.
Strong knowledge in cardiovascular science and valvular heart disease processes.
Experience working closely with Physicians in interventional and surgical environments and ability to communicate and demonstrate confidence in stressful procedural situation is a must.
Experience with Therapeutic Implantable Devices or Interventional/Surgical Clinical experience
Two or more years’ experience specifically with Transcatheter Mitral Devices.
- Bachelor’s Degree Strongly Preferred, Master’s Degree a plus.
Good presentation skills: ability to present material comfortably. Strong teamwork, networking, communication (written/ Verbal) and win-win relationship building skills.
Full understanding of cardiovascular anatomy, pathology, and physiology.
Full understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting.
Must be proficient with computer; Microsoft Office suite; imaging viewer software.
Ability to exercise independent judgment and problem-solving.
Incumbent is required to fully comply with all US and Global regulations, and SOPs in the execution of all job duties.
Quick learner: ability to come up to speed quickly on Edwards’ products and service.
Ability to work positively through confrontation and/or conflicting ideas.
Strong time and territory management skills.
Ability to establish relationships and manage communications with key clinical customers such as physicians, nurses, administrators, etc.
Up to 75% travel, including international
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.