Job description

Edwards has a unique opportunity to join the Transcatheter Heart Valve (THV) group, focused on developing solutions for patients suffering from structural heart disease.

The THV clinical organization is a multi-functional team supporting the product development lifecycle through groundbreaking clinical trial design and execution from first in man through post market surveillance. Through clinical evidence we are able to take our patient-focused innovations to improve the quality of our patient’s lives.

As a Senior Clinical Implant Specialist , you develop clinical education materials in connection with clinical investigations and provide expertise and clinical insights on the device, procedure and protocol throughout the life cycle of the clinical investigation.

Key Responsibilities including but not limited to :
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

Required Qualifications:
Bachelor's Degree
Minimum 5 years of previous medical device and or clinical experience
Ability to travel up to 75%

Preferred Qualifications:
Experience in interventional cardiology or cardiothoracic surgery
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)

General Expectations
Proven expertise in MS Office Suite
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
Work is performed independently on more complex projects and/or lines or work and reviewed for accuracy and soundness

About Edwards Lifesciences

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.

COVID Vaccination Requirement

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, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.

For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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Disability accommodation for employment applicants
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Family and Medical Leave Act (FMLA)
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