Leadless Pacemaker Manager, Field Procedural Specialist Group (Finance)

BIOTRONIK is one of the leading manufacturers of cardio- and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success is based on the competence and results-oriented cooperation of our employees.

The Leadless Pacemaker Manager, Field Procedural Specialist (FPS) Group is responsible for overseeing the activities of the Field Procedural Specialist (FPS) group and will provide technical, clinical, and educational expertise to study sites to ensure safe product use while supporting implants and ongoing study follow-ups during the Global Pivotal Study (GPS) of BIOTRONIK's Leadless Pacemaker. The Field Clinical Manager will report to the VP, Clinical Studies, while functionally interacting with the Leadless Pacemaker Global Training Manager, during the Global Pivotal Study.

Your Responsibilities

Management

• Manage the day-to-day activities of the FPS Group including FPS implant and follow-up visit coverage for study sites, working closely with the Program Coordinator to ensure implant and follow-up coverage.
• Actively participates in the hiring process for the FPS Group with the VP, Clinical Studies and Global Training Manger.
• Collaborate with Clinical Studies Department and collaborate with the Global Training Manager to ensure that the FPS activities align with clinical goals, objectives, and support of the GPS.
• Facilitate and foster collaboration, best practices, and updated troubleshooting techniques with the FPS Group and all effected departments.
• Monitor expense management for the FPS Group per BIOTRONIK travel and expense policies.
• Coordinate all activities and training programs with the Program Coordinator.

Training

• Assess and identify training needs and gaps and provide coaching and development for all direct reports to maintain competency.
• Provide clinical expertise at the BIOTRONIK training labs, including hands on implant procedure training with several physicians at a time in a simulated EP lab setting.
• Educate implanting teams on proper indications for use and Leadless Pacemaker implant procedures.
• 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.

Clinical Study Site Support

• Responsible for implant and follow-up visit procedure support, in compliance with the instructions for use and trial protocol.
• Carry product and work with clinical studies team to ensure adequate product at site.
• Collaborate and partner with the local Field Clinical Studies Engineering team responsible for protocol execution.
• Assist in data collection during implant and follow-up visits to support protocol requirements.
• Provide support on questions regarding device follow up and programming.
• Responsible for monitoring the FPS team's travel arrangements to ensure study site implant and follow-up coverage
• Maintain hospital eligibility/access with various vendor credentialing services.

Communication

• Maintains a high level of communication with study sites and customers, Clinical Studies leadership, and FPS team throughout the Global Pivotal Study.
• Professional written and verbal communication skills.
• Provide updates as needed for technology improvements and next generation needs.
• Submit accurate and timely expense reports.

Your Profile

• Demonstrated minimum of 2 years of proven leadership skills and experience managing diverse teams.
• Preferred experience working on a clinical trial for a Class II or III medical device.
• Bachelor's Degree in engineering, biological sciences, or a related field, OR equivalent or related experience in cardiology or clinical research.
• 5+ years 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.

Travel Requirements

• 75% overnight travel may be required. Some limited international travel may be required.

Physical Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to be independently mobile.

• The employee is also required to interact with a computer for extended periods of time, and communicate with co-workers.
• Must be able to work a minimum of 40 hours / week.
• Must be able to travel

Are you interested? Please apply online through our application management system! We are looking forward to welcoming you.

Location: Lake Oswego, OR

Apply now under: www.biotronik.com/careers

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law. Please note that applications sent by post will only be returned if a sufficiently stamped self-addressed envelope is included.