Medtronic is seeking a Principal Clinical Data Engineer to support clinical studies in Acute Care and Monitoring, troubleshoot, maintain, and develop custom data collection instruments, and collaborate with various departments on data management and analysis.
Requirements
- Experience in data science and analysis.
- Experience with programming languages including Python and Matlab
- Demonstrated skills in “systems thinking” – ability to consider problems, implementations, and impacts at a higher system level
- General knowledge of related principals including electromechanical, tissue optics, physiological signals, etc.
- Experienced in design for six sigma or similar engineering practices
- Experience with pulse oximetry/light-based sensing
- Knowledge of regulatory requirements (FDA, IEC, ISO) and quality management systems.
Responsibilities
- Provides technical support to clinical study sites by serving as the technical resource between engineering and the medical community.
- Support research and development in evaluating concepts of new products and modifying existing devices or therapies.
- Collaborates with various departments on the design, documentation, testing, and implementation of clinical data collection studies, and clinical database review.
- Assist with design and implementation of clinical protocols and data collection systems.
- Develops systems for organizing data to analyze, identify and report data and trends.
- Manages data management issues by reviewing protocols for cross-project consistency, and identifying standard Case Report Form (CRF) modules to meet objectives.
- Review and resolve data discrepancies for standardized data validation systems and procedures.
Other
- Bachelor’s degree and a minimum of 7 years of relevant experience, or advanced degree with a minimum 5 years of relevant experience.
- Medical device development experience, design control, FDA and MDR regulations.
- Proven track record of delivering on complex projects.
- Strong time and project-management skills with a high attention to detail.
- Exceptional communication and interpersonal skills.
