The Field Procedural Specialist (FPS) is responsible for providing technical, clinical, and educational expertise to ensure safe product use while supporting implants and ongoing follow-up visits during the Global Pivotal Study (GPS). The FPS will report to the Manager, Field Procedural Specialist Group within the Clinical Studies Department, interacting with the Leadless Pacemaker Global Training Manager during the Global Pivotal Study and through commercialization.

RESPONSIBILITIES:

Training

• Provide clinical expertise at the company training labs, including hands on implant procedure training with several physicians at a time in a simulated EP lab setting.
• Assist in onsite education and technical training activities with physicians and hospital support staff.
• Educate implanting teams on proper indications for use of the Leadless Pacemaker procedures.
• Provide support on questions regarding device follow up and programming.
• Facilitate onsite training in-service with staff on procedure simulators, including simulated procedures and procedural troubleshooting.
• Support local field representative training to support the study, if applicable.

Clinical Study Site Support

• Responsible for implant and follow-up visit procedure, support in compliance with the instructions for use and trial protocol.
• Carry products and work with clinical studies team to manage site inventory to ensure adequate product at clinical study site.
• Collaborate and partner with the local Field Clinical Studies Engineering team responsible for protocol execution.
• Assist the clinical studies team in data collection during implant and follow-up visits to support protocol requirements.
• Responsible for scheduling individual travel arrangements to ensure site implant and follow-up coverage, with potential for site coverage for emergent checks or at times in other areas of the country.
• Maintain hospital eligibility/access with various vendor credentialing services.

Communication

• Maintains a high level of communication with study sites and customers, Manager, FPS Group, and the GPS study team, including the Field Clinical Studies Engineering group, throughout the Global Pivotal Study.
• FPS and FCSE are expected at implant/ follow-up with FPS focus on implant procedure support and programming and FCSE focus on study protocol requirements
• Professional written and verbal communication skills.
• Provide updates to management to help improve the technology for next generation designs.
• Working with the program coordinator to ensure coverage.
• Submit accurate and timely expense reports.

QUALIFICATIONS:

• Bachelor's degree in engineering, biological sciences, or a related field, OR equivalent or related experience in cardiology or clinical research.
• 3+ years sales and/or cardiac device technical experience in a hospital environment selling or supporting cardiac electrophysiology or cardiovascular implantable product.
• Prior experience with Cardiac Rhythm Management required, with a strong preference of prior leadless pacemaker experience.
• Preference for CCDS certification.
• 75% overnight travel may be required.