Responsibilities will include the management of all aspects of the IDE Clinical Study on our Electrophysiology (EP) catheters, including protocol development, assisting regulatory with IDE and PMA submission, training clinical studies department and field personnel, as well as investigational site personnel on the device and the study, participating in study ablations and follow-ups, analyzing clinical data and writing clinical reports. The ability to make recommendations necessary to promote medical acceptance of the EP catheters and be the internal resource and expert on the catheters are a required asset.

The Clinical Studies Engineer’s responsibilities include the following:

• Develop training and other support materials for investigational EP catheters and procedures.


• Train investigational centers and field personnel on investigational EP catheters.


• Attend study ablation procedures and follow-ups as a technical and clinical resource for the staff at the investigational center.


• Provide clinical and technical feedback to Engineering development groups.


• Provide input for new project planning.


• Attend FDA meetings as the clinical representative to present new catheter features.


• Serve as a resource regarding investigational EP catheters and protocols.


• Lead the protocol design development process.


• Develop training and other support materials for clinical protocols, study procedures, data collection methods and CRF completion and review.


• Assist site coordinators, investigators, and field clinical staff in collecting data.


• Review patient study records submitted to BIOTRONIK.


• Assist the CRA with interfacing with site staff to resolve data discrepancies, compliance, and/or regulatory issues.


• Assist the CRA group with on-site and/or in-house monitoring.


• Organize, summarize, and analyze complex clinical data for clinical report writing and submissions to the FDA.


• Generate clinical reports and publications.


• Assist in writing the clinical portion of FDA submissions.


• Participate in Pacemaker, ICD and CRT trials as needed.


• Maintain and develop professional relationships with investigators and investigative sites.


• Develop solutions for logistical and operational issues.


• Identify and report serious protocol compliance issues.


• Travel is required up to 25% of the time in order to support clinical procedures, training programs, and professional meetings.

Qualifications for the position include:

• More than 3 years experience in a clinical EP setting participating in clinical studies and all types of cardiac ablation procedures.


• Master’s degree in health profession, science, or engineering field with a strong technical and clinical background.


• Previous experience in the medical device industry including interaction with physicians during EP procedures or implantation, follow-up, and trouble-shooting of implantable medical devices.


• Knowledge of project management tools and practices.


• Working knowledge of FDA, ICH, GCP regulations governing clinical trials, standard regulatory and clinical practices and current regulatory issues related to clinical research.


• Demonstrated aptitude in relevant therapeutic areas.


• Additional experience in clinical settings, biostatistics, IDE clinical studies, or medical device sales is beneficial.


• Excellent communication, presentation, interpersonal, and computer skills.


• Excellent organizational skills and attention to detail.


• IBHRE Certification in Cardiac Electrophysiology for the Associated Professional is strongly desired.
   

For more information on BIOTRONIK, Inc. please visit our website at:
www.BIOTRONIK.com
 
For consideration, please APPLY NOW!