Edwards Lifesciences Senior Clinical Implant Specialist -Mitral (Field-Southern CA) in Irvine, California
Edwards has 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 Clinical 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.
Key Responsibilities /Education Support
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, you will serve as active 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 the clinical site and investigator readiness for participation in an investigation and ensuring those key job responsibilities carried out consistently across all studies.
Create, compile and verify required regulatory, legal, and financial documentation to ensure successful study start-up (e.g., site initiation visits, product shipment, the start of patient enrollment) by reviewing the protocol for study-specific criteria to determine what documentation is needed.
Monitor inventory levels initiate deliveries and movements of investigational products according to regulatory and company guidelines. • Monitor the levels and expiration dates of the investigational product in the field.
Coordinate communication between internal and external customers to facilitate the return of the product, according to departmental SOP.
Ensure clinical trials are compliant with regulatory and company guidelines.
Perform other related duties as assigned.
Travel approximately 75% of the time.
Bachelor's Degree required
Minimum five years of previous medical device and or clinical experience required.
Minimum of one year of focused mitral case coverage required.
Registered Nursing Degree (RN), Certified Radiology Technician (CRT),
Operating Room Technician (ORT), or Cardiovascular Technician (RCIS) preferred.
Experience in interventional cardiology or cardiothoracic surgery is preferred.
Minimum of two years prior industry experience also preferred.
Ability to differentiate between different Mitral disease states (FMR, DMR, mixed)
Mitral- clip experience preferred
Solid knowledge in cardiovascular science and medical devices industry preferred.
Solid Knowledge of TEE/TTE/CT imaging.
Knowledge/Support of the transseptal puncture procedure
Knowledge/Support of the transseptal puncture procedure.
Solid Knowledge of TEE/TTE/CT imaging.
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.
Team player, 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 computers.
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 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.