Hybrid Clinical Studies Engineer II — Remote Options

BIOTRONIK SE & Co.KG; Jean (OR); Hybrid; USD 90,000 - 130,000; Full time

Job summary

BIOTRONIK is seeking a Clinical Studies Engineer II to lead clinical investigations, protocol development, CRF design, and data analysis. You will work with investigators, sites, and internal teams to ensure compliant study execution and accurate reporting.

The role requires a health or engineering background, knowledge of FDA and GCP guidelines, and strong communication. Hybrid work from Lake Oswego, OR is available, with travel as needed.

Qualifications

• Bachelor’s degree in a health profession, science, engineering, or related field with strong technical and clinical background.
• Knowledge of FDA regulations, ICH guidelines, GCP, and related regulations governing clinical research.
• Ability to rapidly learn and apply new therapeutic areas and technologies.
• Excellent written and verbal communication and interpersonal skills.

Responsibilities

• Participate in all phases of clinical investigations including design, initiation, enrollment, execution, data analysis, and reporting.
• Lead development and revision of clinical study protocols and CRFs.
• Provide day‑to‑day study management and training to investigators and BIOTRONIK staff.
• Collaborate with cross‑functional teams to resolve data discrepancies and regulatory issues.
• Support FDA submissions and participate in FDA meetings when needed.

Skills

Communication skills

Clinical research knowledge

Biomedical engineering

Project management

FDA regulations knowledge

Education

Bachelor's degree in health, science, engineering

Master's degree preferred

Tools

Clinical data software

MS Office

Statistical analysis

Job description

BIOTRONIK is seeking a Clinical Studies Engineer II to lead clinical investigations, protocol development, CRF design, and data analysis. You will work with investigators, sites, and internal teams to ensure compliant study execution and accurate reporting.

The role requires a health or engineering background, knowledge of FDA and GCP guidelines, and strong communication. Hybrid work from Lake Oswego, OR is available, with travel as needed.