Clinical Studies Engineer II - Cardiac Rhythm Management (CRM)

Biotronik•Oswego, IL

6d•Hybrid

About The Position

BIOTRONIK is seeking an experienced Clinical Studies Engineer II to support clinical investigations involving Cardiac Rhythm Management (CRM) technologies. The role contributes throughout the clinical study lifecycle, from study design and initiation through enrollment, execution, data analysis, reporting, and closeout. It develops and revises study protocols, creates case report forms and supporting documents, and provides day-to-day clinical and technical support to investigative sites, investigators, field personnel, and internal stakeholders. The position requires knowledge of CRM technologies and clinical procedures, including pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices. The engineer reviews study documentation and data for accuracy and compliance, helps resolve operational and regulatory issues, partners with Clinical Data Operations on data analysis, and contributes to clinical reports, scientific publications, and FDA submissions. The role also provides clinical feedback to Engineering and Research and Development, may represent the company in FDA meetings, and may train or mentor newly hired Clinical Studies Engineers. This position has no direct supervisory responsibilities. It is full-time, with a minimum of 40 hours per week, typically Monday through Friday. Work hours may vary based on study-site time zones and business needs, and occasional evening or weekend work may be required. The work location is hybrid from the Lake Oswego, Oregon campus or remote within the United States, based on skills and qualifications. Travel is generally less than two weeks per year but may periodically increase to 25%, including overnight travel within the United States.

Requirements

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 investigations in the medical-device industry, or more than three years of successful experience as a BIOTRONIK Clinical Studies Engineer I with Clinical Studies Certification in the primary product area supported.
Professional experience supporting CRM 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, Good Clinical Practice (GCP), and other applicable clinical research requirements.
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.

Nice To Haves

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 case report forms.
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.

Responsibilities

Apply and further develop expertise in CRM technologies, associated clinical procedures, and cardiac implantable electronic devices, including pacemakers, ICDs, and CRT devices.
Participate in all phases of clinical investigations, including study design, initiation, enrollment, execution, data analysis, clinical report writing, and closeout.
Lead development and revision of clinical study protocols and design case report forms that support accurate, complete, protocol-aligned data collection.
Develop study documents, site and internal training materials, and resources supporting protocols, investigational devices, 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.
Work 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, presenting and explaining device features, study design, and results.
Attend device implants and/or follow-up procedures as needed to maintain current knowledge of devices, clinical utilization, and patient care.
Provide clinical and technical feedback to Engineering and Research and Development, contribute to new project planning, and support training and mentoring of newly hired Clinical Studies Engineers.
Build and maintain professional relationships with investigators and investigative sites, and support additional clinical studies or projects as business needs require.