Edwards Lifesciences Associate Manager, Advanced Clinical Imaging (Irvine, CA) - Transcatheter Mitral and Tricuspid Therapies (TMTT) in Irvine, California
Have you been searching for a role that brings you to the forefront of innovation? We have an outstanding leadership opportunity for you to join an early-stage medical device team boldly designing transcatheter mitral and tricuspid therapies from the ground up!
The Transcatheter Mitral and Tricuspid Therapies (TMTT) division is passionate about developing breakthrough solutions for patients suffering from structural heart disease. Join this rapidly growing, fast paced, dynamic team - and play a pivotal role in managing Edwards Lifesciences sponsored clinical studies, bringing new medical devices from concept to commercialization.
As an Associate Manager in Advanced Clinical Imaging you will provide cardiovascular imaging expertise to support new product and procedure development, patient selection criteria development, patient screening, and early clinical imaging training/case support for both novel and iterative devices.
This role is based in Irvine, California. Comprehensive relocation package is available.
Lead and provide guidance to team members in the analysis, summary, and presentation of clinical baseline, procedural, and follow-up imaging (e.g., CT, echo, MRI, angiography) to provide inputs that support new product development and commercial phase and to support event investigations in multiple projects.
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 and research activities to support new product development.
Provide intraprocedural echocardiographic support during animal or cadaveric studies for product and procedure testing or training activities.
Lead collaborations with NPD team and HCPs to develop imaging patient selection criteria and screening protocol.
Develop structure for training programs and review/approve training content relevant to image analysis for HCPs.
Train field support team and/or HCPs on cardiac imaging procedures.
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 training, guidance, development to team members.
Act as an expert in at least one system and analysis software package
Collaborate in development of imaging AI.
flexibility to support new type of activities relevant to medical imaging procedural development, training, analysis, and system development.
Medical Doctorate with two years or Ph.D. with six years; experience of previous in-hospital and or industry clinical, echocardiographic experience, specifically procedural and structural heart disease TEE and Cardiac CT Required.
Must be strong in medical and clinical research study design, and methodology development.
Strong knowledge of Cardiovascular Physiology and structural heart anatomy.
Able to effectively guide and instruct other imaging specialists in clinical settings on effective imaging equipment operation.
Good imaging analysis software skills (e.g. 3Mensio, TomTec, Vitrea, Circle VI, etc.).
Advanced problem-solving, organizational, analytical, and critical thinking skills.
Requires strong diplomacy, influencing and relationship management skills.
Must be able to work in a team environment, fostering collaboration between inter-departmental teams, HCPs and KOLs.
Extensive knowledge of relevant imaging equipment operation (e.g. 2D or 3D TTE/TEE/ICE, CT, MRI, etc.)
Extensive knowledge and understanding of principles, theories, and concepts relevant to cardiovascular imaging.
Knowledge of Good Clinical Practices.
Ability to manage competing priorities in a fast-paced environment.
Must be able to work in a team environment, frequent inter-organizational including physicians and clinicians, Engineers and R&D Staff.
Represents organization in providing solutions to difficult technical issues associated with specific projects.
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.