Edwards Lifesciences Senior Clinical Implant Specialist (Boston) Mitral in Irvine, California
This is a unique opportunity to join the Transcatheter Heart Valve (THV) group, focused on developing solutions for patients suffering from structural heart disease. As a Senior Implant Specialist, you will represent Edwards during implants (or cases) by providing all necessary equipment and products required for device implants and demonstrate expertise in all aspects of implant and troubleshooting techniques in mitral cases.
• Educate and train physicians, hospital personnel and hospital staff on technical matters relating to our mitral products through conducting and/or coordinating one-on-one training sessions, in-service education programs and Seminars and/or outside symposiums.
• Provide training and resources for hospital staff to enable them to conduct training for their personnel (\"train the trainer\").
• During and following transcatheter cases will serve as effective Edwards representative to physicians and support staff regarding Edwards products, service and support.
• Provide support with clinical investigations in assigned institutions.
CLINICAL TRIAL SUPPORT
• Primary contact within the Clinical Research Department for site management during clinical trials.
• Train members of the CS team to handle cases for the Mitral studies
• Assist CRA in ensuring and documenting clinical site and investigator readiness for participation in an investigation and ensuring those key job responsibilities are carried out in a consistent manner across all studies.
• Create, compile and verify required regulatory, legal, and financial documentation in order to ensure successful study start-up (e.g., site initiation visits, product shipment, start of patient enrollment), by reviewing the protocol for study specific criteria to determine what documentation is needed.
• Monitor inventory levels, initiate shipments and movements of investigational products according to regulatory and company guidelines. Monitor the levels and expiration dates of investigational product in the field.
• Coordinate communication between internal and external customers to facilitate return of product according to departmental SOP.
• Ensure clinical trials are compliant to regulatory and company guidelines.
• Perform other related duties as assigned.
• Travel approximately 75% of the time.
• A minimum of five years’ experience is required. Experience in interventional cardiology or cardiothoracic surgery is preferred. Minimum two years prior industry experience also preferred.
• A minimum of one year of focused mitral case coverage required
Knowledge/Support of the transseptal puncture procedure.
Solid Knowledge of TEE/TTE/CT imaging
Ability to differentiate between different Mitral disease states (FMR, DMR, mixed)
Mitral- clip experience preferred
• Registered Nursing Degree (RN), Certified Radiology Technician (CRT), Operating Room Technician (ORT), or Cardiovascular Technician (RCIS) preferred.
• Solid knowledge in cardiovascular science and medical devices industry preferred.
• Solid Knowledge of mitral anatomy and current mitral procedures
• Quick learner; ability to come up to speed quickly on Edwards’s products and services.
• Good presentation skills; ability to present material comfortably.
• Good teaming, networking, communication (written/verbal) and win-win relationship building skills.
• Ability to work positively through confrontation and/or conflicting ideas.
• Strong time and territory management skills.
• Must be proficient with computer.
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.