For California, the base pay range for this position is $134,000 - $190,000 (highly experienced).
Employment
full time
Employer job description
From Edwards Lifesciences's posting. “We” and “our” refer to the employer.
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:
The Senior Specialist, Clinical Development serves as a subject matter expert (SME) supporting the advancement of transcatheter therapies through hands-on clinical engagement, procedural innovation, and continuous learning. This role partners cross-functionally with physicians, R&D, and commercial teams to support complex cases, develop procedural techniques, and translate real-world clinical insights into next-generation device and therapy improvements.
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.
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