Clinical Studies Engineer II — Drive Device Trials (Hybrid/Remote)

BIOTRONIK; Lake Oswego (OR); Hybrid; USD 95,000 - 125,000; Full time

Job summary

BIOTRONIK is seeking a Clinical Studies Engineer II to lead and support clinical investigations for medical devices. You will design protocols, CRFs, and study materials, manage sites, and ensure compliant data collection and reporting across study lifecycles.

Collaborating with cross-functional teams, you will contribute to FDA submissions, communicate with investigators, and maintain device-specific clinical expertise through implants and follow-up procedures.

Qualifications

• 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, GCP, and other regulations governing clinical research.
• Demonstrated ability to develop expertise in therapeutic areas and quickly learn new technologies.

Responsibilities

• Participate in all phases of clinical investigations including study design, initiation, enrollment, execution, data analysis, and reporting.
• Lead the development and revision of clinical study protocols.
• Design CRFs to support data collection and analysis per study protocols.
• Provide day-to-day study management and support to investigative sites.
• Train sites and BIOTRONIK personnel on protocols, devices, and data collection requirements.

Skills

Clinical research

Regulatory knowledge

Communication

Project management

Education

Bachelor's degree in health science/engineering

Tools

Clinical study tools

Job description

BIOTRONIK is seeking a Clinical Studies Engineer II to lead and support clinical investigations for medical devices. You will design protocols, CRFs, and study materials, manage sites, and ensure compliant data collection and reporting across study lifecycles.

Collaborating with cross-functional teams, you will contribute to FDA submissions, communicate with investigators, and maintain device-specific clinical expertise through implants and follow-up procedures.