Senior Specialist, Clinical Education, Clinical Development
Edwards Lifesciences
Senior Specialist, Clinical Education, Clinical Development
Job Description
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 guidance during implants, including contingency planning to address unforeseen occurrences in support novel devicesDocument procedural case observations for insights in investigating post procedural events. Support enrollment discussions and assistance with issue escalation with Principal Investigator and research teamDevelop 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 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 complex design control and trial-related documentation and support all complaint and investigational analyses supporting the therapy. Make recommendations for improvementsThis position is on site in Irvine, Ca Full time with up to 50% travel nationwideWhat you’ll need (Required):Bachelor's Degree in Engineering or Scientific field , 4 years experience including either industry or industry/education Required orMaster's Degree or equivalent in Engineering or Scientific field, 3 years experience including either industry or industry/education Required orWhat else we look for (Preferred):Demonstrated experience in customer-facing roles, including direct engagement with physicians and leading training and procedures on procedural execution and best practicesSubstantial knowledge and understanding of principles, theories, and concepts relevant to Engineering and cardiovascular sciencFull knowledge of cardiovascular anatomy, pathology, and physiologyStrong problem-solving, organizational, analytical, and critical thinking skillsSubstantial understanding of medical device regulatory requirements and documents, adverse events reportingGood leadership skills and ability to influence change; acts as a resource for colleagues with less experienceStrong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skillsBasic understanding of statistical techniquesPrevious experience working with lab preferredKnowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturingproven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and ExcelAdhere 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/controlAligning 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 (CA), the base pay range for this position is $134,000 to $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.
Locations
- USA - California – Irvine
Salary
134,000 - 190,000 USD / yearly
Skills Required
- customer-facing rolesintermediate
- cardiovascular anatomyintermediate
- and adherence to Edwards Environmental Healthintermediate
- Microsoft Office Suite including Wordintermediate
Required Qualifications
- Bachelor's Degree in Engineering or Scientific field , 4 years experience including either industry or industry/education Required or (experience, 4 years)
- Master's Degree or equivalent in Engineering or Scientific field, 3 years experience including either industry or industry/education Required or (experience, 3 years)
- Bachelor's Degree in Engineering or Scientific field , 4 years experience including either industry or industry/education Required or (experience, 4 years)
- Master's Degree or equivalent in Engineering or Scientific field, 3 years experience including either industry or industry/education Required or (experience, 3 years)
Preferred Qualifications
- Demonstrated experience in customer-facing roles, including direct engagement with physicians and leading training and procedures on procedural execution and best practices (experience)
- Substantial knowledge and understanding of principles, theories, and concepts relevant to Engineering and cardiovascular scienc (experience)
- Full knowledge of cardiovascular anatomy, pathology, and physiology (experience)
- Strong problem-solving, organizational, analytical, and critical thinking skills (experience)
- Substantial understanding of medical device regulatory requirements and documents, adverse events reporting (experience)
- Good leadership skills and ability to influence change; acts as a resource for colleagues with less experience (experience)
- Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills (experience)
- Basic understanding of statistical techniques (experience)
- Previous experience working with lab preferred (experience)
- Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing (experience)
- proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and Excel (experience)
- 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 (experience)
- 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 (CA), the base pay range for this position is $134,000 to $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. (experience)
Responsibilities
- 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 guidance during implants, including contingency planning to address unforeseen occurrences in support novel devices
- 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 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 complex design control and trial-related documentation and support all complaint and investigational analyses supporting the therapy. Make recommendations for improvements
- This position is on site in Irvine, Ca Full time with up to 50% travel nationwide
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