Senior Specialist, Clinical Education, Clinical Development

Edwards Lifesciences Gruppe; Santa Ana (CA); On-site; USD 134,000 - 190,000; Full time

Job summary

Edwards Lifesciences Irvine seeks a Senior Specialist, Clinical Development to advance transcatheter therapies through hands-on clinical engagement, procedural innovation, and continuous learning. You will partner with physicians, R&D, and commercial teams to support complex cases and translate real-world insights into next-generation device improvements.

On-site in Irvine, CA, this full-time role offers up to 50% travel nationwide.

Qualifications

• Bachelor’s or Master’s degree in engineering or science.
• Experience in clinical development or industry/education collaboration.
• Strong documentation and regulatory awareness required.

Responsibilities

• SME supporting advancement of transcatheter therapies through hands-on clinical engagement.
• Represent TMTT during complex research cases with investigators and staff.
• Document procedural observations and support enrollment discussions.
• Develop materials and education on device handling, implantation, and troubleshooting.
• Coordinate imaging training and document design/control for trials and investigations.
• On-site Irvine, CA, full-time with up to 50% travel nationwide.

Skills

SME in clinical dev

Clinical engagement

Procedural training

Cross-functional collaboration

Documentation

Education

Bachelor's degree in engineering/science

Master's degree or equivalent in engineering/science

Tools

Microsoft Office

Excel

PowerPoint

Word

Access

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 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

What you’ll need (Required):

• Bachelor's Degree in Engineering or Scientific field, with 4 years experience including either industry or industry/education or
• Master's Degree or equivalent in Engineering or Scientific field, with 3 years experience including either industry or industry/education

What else we look for (Preferred):

• Tricuspid or Mitral procedural experience within OR Cath Lab as Proctor or Industry Case Support
• Demonstrated experience in customer‑facing roles, including direct engagement with physicians and leading training and procedures on procedural execution and best practices
• Substantial knowledge and understanding of principles, theories, and concepts relevant to Engineering and cardiovascular science
• Full knowledge of cardiovascular anatomy, pathology, and physiology
• Strong problem‑solving, organizational, analytical, and critical thinking skills
• Substantial understanding of medical device regulatory requirements and documents, adverse events reporting
• Good leadership skills and ability to influence change; acts as a resource for colleagues with less experience
• Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
• Basic understanding of statistical techniques
• Previous experience working with lab preferred
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and Excel
• 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 (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.