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Senior Specialist, Clinical Development Imaging (Irvine, CA) TMTT

Company: Edwards Lifesciences Corp
Location: Irvine
Posted on: January 16, 2022

Job Description:

We have an exciting opportunity for an exceptional Senior Clinical Imaging professional to join a team that is boldly designing Transcatheter Mitral and Tricuspid Therapies from the ground up. TMTT we are dedicated to solving the complex challenges of mitral and tricuspid disease to transform treatment and significantly improve patients' lives.
As the Senior Specialist of Clinical Development Imaging, you will perform image analysis and assessment to support new product and procedure development. Develop patient selection criteria, perform retrospective image analysis, provide intra-procedure support for physician training and cutting-edge procedures, and provide input on evolving aspects of the product development process.
The time is now to join TMTT and shape mitral and tricuspid therapies that will transform treatment. Do not miss your chance to be part of a dynamic, challenging, and rewarding environment that offers potential for growth and professional advancement for the right candidate.
Key Responsibilities including but not limited to:



  • Analyze imaging and or oversee third party image analysis for patient screening and contribute an opinion to the assessment of potential cases for early feasibility and clinical study candidates


  • Partner internally and externally in the advancement of next generation imaging technologies


  • Represent the clinical development team during complex clinical situations with investigating physicians, hospital staff and clinical research coordinators by providing on-site, real-time guidance during clinical cases


  • Support may include, but not limited to:


  • Provide on-site cardiac imaging support and guidance during clinical procedures performed on humans to ensure optimal imaging during the implantation of transcatheter devices


  • Provide education on 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 update


  • Analyze, summarize, and present clinical screening, procedural, and follow-up imaging (e.g., CT, echo, MRI, angiography) to provide inputs that support new product and procedure development and to support event investigation


  • Create training content relevant to imaging procedures and image analysis for health care professionals and or field support teams. Train field support team and or HCPs on cardiac imaging procedures as appropriate

  • Work with sites and imaging transfer vendor to answer queries and troubleshoot technical issues

    Basic Requirements:

    • Bachelor's Degree AND 5 years clinical echocardiography experience

      OR


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


      • Experience in the cardiac cath lab

      • Ability to travel up to 50% (domestic & some international)

        Preferred Qualifications:


        • Interventional Echo Imaging experience necessary, particularly with 2D/3D TEE


        • Excellent computer skills, including Microsoft Office Suite


        • Good imaging analysis software skills (e.g., TomTec, Xcelera, 3Mensio, Vitrea, Circle VI, etc.)

        • Substantial knowledge of relevant imaging equipment operation (e.g., 2D or 3D TTE/TEE/ICE, CT, MRI, etc.)

          General Expectations:


          • Significant experience and understanding of principles, theories, and concepts relevant to cardiovascular imaging


          • Solid knowledge of GCP (Good Clinical Practices)


          • Excellent presentation skills: ability to present material comfortably. team player, networking, communication (written/ verbal) and relationship building skills


          • Ability to exercise independent judgment and problem-solving


          • Quick learner: ability to come up to speed quickly


          • Work is performed independently on complex projects


          • Ability to work positively through confrontation and or conflicting ideas


          • Able to effectively guide and instruct other imaging specialists in clinical settings on effective imaging equipment operation


          • Requires stout diplomacy, influencing and relationship management skills


          • Demonstrated problem-solving and critical thinking skills


          • Must be able to work in a team environment, fostering collaboration between inter-departmental teams, HCPs, and KOLs

          • Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines

            Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
            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 patient-facing and in-hospitals positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who enter a hospital or healthcare facility as part of their role. If hired and your position meets this criteria, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.

Keywords: Edwards Lifesciences Corp, Irvine , Senior Specialist, Clinical Development Imaging (Irvine, CA) TMTT, Healthcare , Irvine, California

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