Clinical Research Engineer II — Hybrid/Remote

BIOTRONIK; Lake Oswego (OR); Hybrid; USD 90,000 - 120,000; Full time

Job summary

BIOTRONIK in Lake Oswego, OR is seeking a Clinical Studies Engineer II to join the Clinical Studies team. You will support clinical investigations through protocol development, site training, data analysis, and regulatory submissions.

The role involves cross-functional collaboration and requires strong regulatory knowledge and communication skills. Hybrid work arrangements apply with travel as needed.

Qualifications

• Bachelor's degree in health, science or engineering with clinical background.
• Knowledge of FDA regulations, ICH GCP and related clinical research standards.
• Ability to rapidly learn new therapeutic areas and technologies.
• Strong written, verbal and interpersonal communication.

Responsibilities

• Participate in all phases of clinical investigations from design to reporting.
• Lead protocol development and CRF design for data collection.
• Provide day-to-day study management and site support.
• Train sites and BIOTRONIK personnel on protocols and devices.
• Collaborate with teams to resolve data discrepancies and regulatory issues.

Skills

Regulatory knowledge

Clinical data analysis

Cross-functional collaboration

Documentation & reporting

Communication skills

Study protocol development

Education

Bachelor's degree in health/science/engineering

Master's degree (preferred)

Tools

GCP/IData regulatory tools

FDA submission support tools

Job description

BIOTRONIK in Lake Oswego, OR is seeking a Clinical Studies Engineer II to join the Clinical Studies team. You will support clinical investigations through protocol development, site training, data analysis, and regulatory submissions.

The role involves cross-functional collaboration and requires strong regulatory knowledge and communication skills. Hybrid work arrangements apply with travel as needed.