Edwards Lifesciences Associate Manager, Advanced Quality Imaging - 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 bringing new medical devices to commercialization.
As an Associate Manager in Advanced Imaging Evaluations you will build and drive a team to provide cardiovascular imaging expertise to assess results and recommendations for investigations on commercial and clinical studies for both novel and iterative devices. This role is based in Irvine, California and we provide a comprehensive relocation package for those living out of the area.
• Build and lead a growing team that completes imaging evaluations for complaints by analyzing pre, intra- and post procedural imaging and oversee third party image analysis within multiple modalities and multiple anatomies
• Stratify and optimize investigation workflows to ensure effective, efficient, and scalable processes that enable the growth of TMTT’s transformative therapies
• Provide guidance and advance imaging subject matter expertise to cross functional teams to support determination of root cause and next steps for investigations. Analyze complex images within event investigations for multiple programs
• Understands, manages, and prioritize complaint trends to support Product Risk Assessments (PRAs) and CAPAs (Corrective and Preventative Actions) as needed
• Partner across the organization with Quality Engineering, Clinical Affairs, Clinical Development, R&D, Operations & more to resolve complex investigations and optimize processes
• Develop talent development plans in alignment with individual and business growth strategies
• Establish assigned objectives and responsible for archiving and/or exceeding qualify objectives
• Other incidental duties
Education and Minimum Requirements:
Bachelor's Degree in in biological or life sciences, animal science, or other related scientific or technical field and 8 years experience of previous in-hospital and/or industry clinical echocardiographic experience
Certification in RDCS (Registered Diagnostic Cardiac Sonographer), within ARSMS (American Registry for Diagnostic Medical Sonography) or equivalent certification and 10 years of relevant in-hospital and/or industry clinical echocardiographic experience
People-management experience for teams of 3+ staff members
Procedural echo imaging experience for structural heart cases
Additional Talents and General Expectations:
• Mitral &/or tricuspid valve device or echo proctoring experience
• Strong knowledge of cardiovascular physiology and structural heart anatomy.
Demonstrated leadership abilities to motivate and align individuals to short term and strategic goals
• Excellent problem-solving, organizational, analytical, and critical thinking skills including high discretion/judgment in decision making.
• Good imaging analysis software skills (e.g. 3Mensio, TomTec, Vitrea, Circle VI, etc.).
• Extensive knowledge and understanding of principles, theories, and concepts relevant to cardiovascular imaging.
• 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.
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
• Able to travel up to 5% of the time.
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.