United Spinal Association Jobs

Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.

Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you’ll make an impact:

• Clinical Education Senior Specialist who provides procedural guidance to new clinical specialist and clinicians in the clinical study setting with good understanding of image-based navigation

• Lead trainer supporting new clinical specialist training and physician training for new and existing clinical trial sites, and providing input on evolving aspects of the product development process.

• Training and guiding new hires on TMTT Devices, the device specifications and IFUs, and device prep.

• Provide mentoring and instruction on case planning, case paperwork and end of case device accountability.

• Provide on-site, real-time guidance during clinical implants, including contingency planning to address unforeseen occurrences in support of assigned clinical investigations.

• 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 steps

• 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

• Travel up to 75% required within US Nationwide

What you'll need (Required):

• Bachelor's Degree In related medical device and/or with 5 years of experience in Advanced Cardiac Sonographer clinical experience / Clinician experience in intra-operative procedures of previous medical device and/or clinical experience

• Certification in RDCS (Registered Diagnostic Cardiac Sonographer) within ARDMS (American Registry for Diagnostic Medical Sonography) required

• Or Certification such as: RDCS (Registered Diagnostic Cardiac Sonographer) through ARDMS or RCS from CCI and with 7 years of previous in-hospital and/or industry experience in clinical echocardiography

What else we look for (Preferred):

• Previous medical device and or clinical experience

• Experience with supporting cases relating to mitral and tricuspid valves

• Minimum of 4 years of relevant Industry Experience or Clinical Experience is required.

• Experience with Therapeutic Implantable Devices or Interventional/Surgical Clinical experience is preferred.

• Interventional Echo-navigation Imaging experience, particularly with 2D/3D TEE and CT-imaging for screening is valuable and strongly preferred.

• Experience in Interventional Cardiology/Cardiac Cathlab is preferred, Cardiac Surgery experience is also valuable.

• Clinical engineering experience from industry-related positions that support clinical development and clinical case support may be considered.

• Strong knowledge in cardiovascular science and valvular heart disease processes

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.