Clinical Studies Engineer

Clinical Studies Engineer

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 looking to add a Clinical Studies Engineer to our Clinical Studies department. BIOTRONIK is looking to add a Clinical Studies Engineer to our growing team.

The Clinical Studies Engineer works collaboratively with a team and is responsible for gaining and utilizing knowledge of BIOTRONIK medical devices and clinical procedures to support clinical trial design, development, execution, and outcomes reporting for clinical studies in cardiac rhythm management (CRM) and vascular intervention.

In this role, you will help shape clinical trials for new product, new features, or new ideas that positively impact our patients and customers.

Your Responsibilities

• Contribute to all phases of clinical study including development of study design, writing protocol, determining data collection requirements and methods, creating study and training documents, monitoring device and procedure-related case report forms, and preparing clinical reports
• Collaborate with statistical programming team to clean, organize, summarize, and analyze complex clinical data for clinical report writing and, when applicable, for submissions to the FDA
• Support clinical physician consultants, including key opinion leaders in the respective field, to develop abstracts and manuscripts
• As part of a study team, provide day-to-day study support, plus interfaces with site coordinators, investigators, field clinical staff, and other company representatives
• Assemble clinical and technical feedback from various sources, including Advance Product Support, Engineering or Research and Development groups, to support informed decision making
• Keep current with changes in cardiac devices, device utilization, and patient care by engaging in learning opportunities, including review of relevant literature, attending trainings or conferences, attending implant cases, and supporting study site visits
• Conduct research and provide input for new project planning
• Assist with development of FDA communications, including pre-submissions and PMA applications, and attend FDA meetings as a clinical representative to present and explain new device features, study design, or study results

Your Profile

• Bachelor’s degree in health profession, science, or engineering field with a strong technical and clinical background (Master’s degree preferred)
• Two or more years of relevant post-education / on-the-job experience in clinical research
• Demonstrated aptitude in and knowledge of CRM is a plus
• Excellent communication, presentation, interpersonal, and computer skills
• Strong analytical skills to support problem solving and critical thinking, proven organizational skills, and attention to detail
• Ability to work both independently and as a part of a team
• Working knowledge and understanding of FDA, ICH, GCP regulations governing clinical trials, standard regulatory and clinical practices and current regulatory issues related to clinical research

Position Type / Expected Hours of Work

This is a full-time position. Standard days of work are Monday through Friday. Hours of work may vary depending on time zone supported.

Occasional evening and weekend work may be required as job duties demand. May be based remotely depending on qualifications.

Travel Requirements

• Travel to support or observe clinical procedures, study center training, and meetings is typically limited (
30+ days ago