Senior Specialist, Clinical Education Imaging, Clinical Development

• Represent TMTT during complex research cases (ESAPCU, clinical trial, commercial) with investigating physicians, hospital staff and clinical research coordinators by providing on-site, real-time imaging and clinical guidance during implants, including contingency planning to address unforeseen occurrences in support novel devices.
• Provide expertise and clinical insights on the device, procedure, and protocol throughout the product life cycle from early studies through commercialization.
• Document procedural case observations for insights in investigating post procedural events. Support enrollment discussions and assistance with issue escalation with Principal Investigator and research team.
• Develop materials and provide education on all aspects of the device, device handling, implantation and troubleshooting techniques related to equipment, tools and products required for device implants.
• Develop, analyze, and optimize the design of more complex procedures, testing, and therapies leveraging substantial understanding of clinical imaging. Coordinate all clinical imaging training and instruction for cross-functional teams as products move from ESAPCU to early human use to the commercial setting. Create more complex design control and trial-related documentation and support all complaint and investigational analyses supporting the therapy. Make recommendations for improvements.

What you’ll need (Required):

• Bachelor's Degree in biological or life sciences, animal science, or other related scientific or technical field with 5 years experience of independent echo sonography scanning in a clinical setting or equivalent work experience based on Edwards criteria
• Certification in RDCS (Registered Diagnostic Cardiac Sonographer) within ARDMS (American Registry for Diagnostic Medical Sonography) or equivalent certification
• This position is on site in Irvine, Ca full time. Relocation is available.
• Must be willing to travel up to 50% nationwide

What else we look for (Preferred):

• Able to effectively guide and instruct other imaging specialists in clinical settings on effective imaging equipment operation
• Must be able to work in a team environment, fostering collaboration between inter-departmental teams, HCPs and KOLs
• Substantial knowledge and understanding of principles, theories, and concepts relevant to Engineering and cardiovascular science
• Structural Heart Experience in tricuspid and mitral valves
• Substantial understanding of medical device regulatory requirements and documents, adverse events reporting
• Able to effectively guide and instruct other imaging specialists in clinical settings on effective imaging equipment operation
• Strict attention to detail
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to manage competing priorities in a fast-paced environment
• Work is performed independently on mid-to-large scale projects and will participate in determining objectives of assignment; plans schedules and arranges own activities in accomplishing objectives
• Acts as a resource for colleagues with less experience
• Contributes to the completion of significant organizational projects and goals; Input on overall objectives and long-range goals of the organization is given serious consideration
• Erroneous decisions or failure to achieve objectives would normally have a serious effect upon the administration of the organization
• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
• Excellent written and verbal communication skills including customer negotiating and relationship management skills, strong diplomacy, influencing and relationship management skills
• Excellent problem-solving, organizational, analytical, and critical thinking skills
• Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and Excel
• Good imaging analysis software skills (e.g., 3Mensio, TomTec, Vitrea, Circle VI, etc.)]
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California, the base pay range for this position is $134,000 - $190,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

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