Clinical Studies Engineer II - Cardiac Rhythm Management (CRM)

BIOTRONIK is hiring a Clinical Studies Engineer II to support clinical investigations involving cardiac rhythm technologies and medical devices. The role contributes throughout the study lifecycle, provides clinical and technical support to investigators and study sites, and supports clinical data analysis, reporting, and regulatory submissions.

Responsibilities:

• Apply and further develop expertise in Cardiac Rhythm Management technologies, associated clinical procedures, and cardiac implantable electronic devices, including pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices
• Participate in all phases of clinical investigations, including study design, initiation, enrollment, execution, data analysis, clinical report writing, and study closeout
• Lead the development and revision of clinical study protocols and design case report forms (CRFs) that support accurate, complete, and protocol-aligned data collection
• Develop study documents, site and internal training materials, and other resources supporting protocols, investigational devices, study procedures, and CRF completion
• Provide day-to-day study management and clinical and technical support to investigative sites, investigators, site coordinators, field clinical personnel, sales representatives, and internal stakeholders
• Train investigative sites and BIOTRONIK personnel on clinical protocols, investigational devices, procedures, and clinical data requirements
• Review and/or monitor CRFs, source documents, and study records in accordance with BIOTRONIK procedures and applicable regulatory requirements
• Partner with study teams, field personnel, and investigative sites to resolve data discrepancies, protocol deviations, compliance concerns, regulatory issues, and operational challenges
• Partner with Clinical Data Operations to clean, organize, summarize, and analyze complex clinical data
• Generate clinical reports, contribute to scientific publications, and support clinical content for FDA submissions
• Participate as a clinical representative in FDA meetings when needed, including presenting and explaining device features, clinical study design, and study results
• Attend device implants and/or follow-up procedures as needed to maintain current knowledge of cardiac rhythm devices, clinical utilization, and patient care
• Provide clinical and technical feedback to Engineering and Research and Development, contribute to new project planning, and support the training and mentoring of newly hired Clinical Studies Engineers
• Build and maintain effective professional relationships with investigators and investigative sites, and support additional clinical studies or projects as business needs require

Requirements:

• Working knowledge of FDA regulations, ICH guidelines, Good Clinical Practice (GCP), and other standards governing medical-device clinical research
• Applied knowledge of CRM therapies, devices, terminology, and associated implant and follow-up procedures
• Ability to translate complex clinical, technical, and study information for investigative sites and cross-functional stakeholders
• Ability to independently manage multiple priorities and contribute effectively within cross-functional teams
• Strong clinical study problem-solving, judgment, organization, and attention to detail
• Strong written and verbal communication, presentation, training, and interpersonal skills
• Ability to work effectively with clinical study data, protocols, CRFs, source documentation, reports, and regulatory content
• Ability to build credibility and productive relationships with investigators, clinical sites, field teams, and internal partners
• Bachelor's degree in a health profession, biological or life science, engineering, or a related field with a strong technical and clinical foundation
• More than three years of professional experience supporting clinical studies or clinical investigations in the medical-device industry, or more than three years of successful experience as a Clinical Studies Engineer I within BIOTRONIK Clinical Studies with completion of Clinical Studies Certification in the primary product area supported
• Professional experience supporting Cardiac Rhythm Management technologies and/or cardiac implantable electronic devices, such as pacemakers, ICDs, or CRT devices
• Demonstrated experience supporting medical-device clinical investigations and working with investigative sites, clinical study protocols, clinical data, and study documentation
• Working knowledge of FDA regulations, ICH guidelines, GCP, and other applicable clinical research requirements
• Master's degree in a health profession, biological or life science, engineering, or a related discipline
• Experience supporting Investigational Device Exemption (IDE) clinical studies
• Experience developing clinical study protocols and CRFs
• Experience with clinical data analysis, clinical report writing, and/or scientific publications
• Experience preparing clinical content for FDA submissions or participating in regulatory-agency interactions
• Clinical or field experience supporting CRM device implants and/or follow-up procedures