Clinical Studies Engineer II

Biotronik • Oswego, IL

4d • Hybrid

About The Position

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. BIOTRONIK is seeking a Clinical Studies Engineer II to join our Clinical Studies team. In this role, you will play an important part in the planning, execution, and successful completion of clinical investigations involving innovative medical device technologies. You will develop an in-depth understanding of BIOTRONIK products, clinical procedures, and relevant therapeutic areas while serving as a clinical and technical resource for investigative sites, field personnel, and internal stakeholders. Working collaboratively with cross-functional teams, investigators, and study sites, you will support clinical investigations throughout the study lifecycle, including protocol development, study initiation, enrollment, data analysis, clinical reporting, and regulatory submissions. This role offers the opportunity to contribute to the development of clinical evidence supporting BIOTRONIK technologies while helping ensure the successful and compliant conduct of clinical studies.

Requirements

• Bachelor's degree in a health profession, science, engineering, or related field with a strong technical and clinical background.
• Working knowledge of FDA regulations, ICH guidelines, Good Clinical Practice (GCP), and other regulations and standards governing clinical research.
• Demonstrated ability to develop expertise in relevant therapeutic areas and quickly learn and integrate knowledge of new technologies and clinical applications.
• Strong written and verbal communication, presentation, and interpersonal skills.
• Excellent organizational skills and attention to detail.
• Ability to manage multiple priorities and work effectively both independently and as part of a cross-functional team.
• Strong computer skills and ability to work effectively with clinical study data and documentation.
• More than three years of successful experience as a Clinical Studies Engineer I within BIOTRONIK's Clinical Studies department, along with completion of Clinical Studies Certification in a product area of primary study support; or Comparable clinical studies experience with another organization in a similar position or relevant field.

Nice To Haves

• Master's degree in a health profession, science, engineering, or related discipline.
• Experience in a clinical setting, biostatistics, IDE clinical studies, and/or medical device support.
• Previous experience supporting medical device clinical investigations.

Responsibilities

• Participate in all phases of clinical investigations, including study design, initiation, enrollment, study execution, data analysis, and clinical report writing.
• Lead the development and revision of clinical study protocols.
• Design case report forms (CRFs) to support accurate, comprehensive data collection and analysis in accordance with study protocols.
• Develop study documents, training materials, and other resources supporting clinical protocols, study procedures, and CRF completion.
• Provide day-to-day study management and support to investigative sites.
• Serve as a clinical and technical resource for site coordinators, investigators, field clinical personnel, sales representatives, and other internal stakeholders.
• Train investigative sites and BIOTRONIK personnel on clinical protocols, investigational devices, study procedures, and data collection requirements.
• Support sites and field personnel in collecting complete, accurate, timely, and compliant clinical data.
• Review and/or monitor case report forms, source documents, and other study records in accordance with BIOTRONIK procedures and applicable regulatory requirements.
• Collaborate with study teams, field personnel, and investigative sites to resolve data discrepancies, compliance concerns, and regulatory issues.
• Identify and report significant protocol compliance issues and support appropriate resolution.
• Develop solutions to logistical and operational challenges that arise during study execution and communicate recommendations to appropriate stakeholders.
• Build and maintain strong professional relationships with investigators and investigative sites.
• Partner with Clinical Data Operations to clean, organize, summarize, and analyze complex clinical data.
• Generate clinical reports and contribute to scientific publications.
• Support preparation of clinical content for FDA submissions.
• Participate in FDA meetings as a clinical representative when needed, including presenting and explaining device features, clinical study design, and study results.
• Develop an in-depth understanding of BIOTRONIK products and associated clinical procedures, which may include technologies within cardiac rhythm management, vascular intervention, and/or spinal cord stimulation.
• Develop training and clinical study support materials for investigational or study devices and procedures.
• Collaborate with Advanced Product Support and other internal teams to address technical and study-related questions.
• Attend device implants and/or follow-up procedures as needed to remain current on devices, clinical utilization, and patient care.
• Provide clinical and technical feedback to Engineering and Research & Development teams as needed.
• Contribute clinical expertise to new project planning and development initiatives.
• Support the training and mentoring of newly hired Clinical Studies Engineers.
• Provide support to other clinical studies and projects as business needs require.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level