Clinical Studies Engineer II - Cardiac Rhythm Management (CRM)

Clinical Studies Engineer II - Cardiac Rhythm Management (CRM)

BIOTRONIK is seeking an experienced Clinical Studies Engineer II with Cardiac Rhythm Management (CRM) and medical-device clinical research experience to support clinical investigations involving cardiac rhythm technologies. This role contributes across the clinical study lifecycle, including protocol and case report form development, study initiation and execution, investigative-site support, clinical data review and analysis, clinical reporting, and regulatory submissions.

The Clinical Studies Engineer II serves as a clinical and technical resource for investigators, study sites, field personnel, and internal stakeholders. The position requires existing knowledge of CRM technologies and clinical procedures, along with the ability to apply that expertise to the compliant execution of medical-device clinical investigations. The role collaborates closely with Clinical Data Operations, Engineering, Research and Development, Advanced Product Support, regulatory partners, and other cross-functional teams.

Essential Functions:

• 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.

Competencies:

• 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.

Required Education and Experience:

• 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.

Preferred Education and Experience:

• 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.

Supervisory Responsibilities:

This position does not have direct supervisory responsibilities. The employee may support the training and mentoring of newly hired Clinical Studies Engineers.

Work Environment:

This position operates in a professional office and remote-work environment and routinely uses standard office equipment, including computers and phones. The employee also works in clinical settings, including hospitals and investigative sites, when attending device procedures, conducting training, or supporting clinical investigations. Work location is hybrid from the Lake Oswego, Oregon campus or remote within the United States based on skills and qualifications.

Physical Demands:

The physical demands described here 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.

• Ability to be independently mobile and travel to clinical sites, procedures, training sessions, and meetings as required.
• Ability to interact with a computer for extended periods and communicate effectively with coworkers and external stakeholders.
• Ability to perform the essential functions of the role in professional office, remote-work, hospital, and clinical-site environments.

Position Type/Expected Hours of Work:

This is a full-time position requiring a minimum of 40 hours per week. Standard workdays are Monday through Friday. Work hours may vary based on the time zones of supported study sites and business needs; occasional evening or weekend work may be required.

Travel:

Travel is generally limited to less than two weeks per year for clinical procedures, investigative-site training, and meetings. Depending on study needs and the phase of a clinical investigation, travel may periodically increase to up to 25% and may include overnight travel within the United States.

Additional Eligibility Qualifications:

• Ability to meet BIOTRONIK requirements for access to healthcare facilities and investigative sites, as applicable.
• Ability to maintain required training and certifications related to clinical research, product support, and assigned clinical studies.

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

Location: Lake Oswego, OR | Working hours: Full-time | Type of contract: Undefined

Apply now under: www.biotronik.com/careers

Job ID: 62780 | USA | BIOTRONIK Inc.