Experteer Overview
In this role you apply clinical expertise to support product quality and patient safety across the product lifecycle. You collaborate with cross‑functional teams to influence decisions and provide medical guidance on complaints and regulatory matters. You evaluate imaging and clinical data to drive complex investigations and risk assessments. You will develop clinically based training and help standardize processes to improve outcomes for patients worldwide.
Compensaciones / Ventajas
• Provide clinical guidance and final direction to complaint staff and engineers on event interpretation, investigation, coding, regulatory reporting, and closure
• Evaluate imaging and clinical information (e.g., Echo, Fluoroscopy, CT) related to cardiovascular imaging for investigations
• Contribute to Product Risk Assessments and work with Product Safety on decision matrices and patient-risk decisions
• Develop and deliver clinically based training on anatomy, conditions, products, procedures, and clinical event interpretation
• Review regulatory submissions or requests and perform ad hoc clinical analyses
• Communicate clinical conclusions and trends to Quality, Manufacturing, Product Safety, and Product Development stakeholders
• Participate in cross-functional discussions and audits as a clinical SME
• Provide clinical interpretation for complaint-related activities, including records review and literature analysis
• Identify opportunities for process improvement and standardization of procedures, tools, and training materials
• Other incidental duties as needed
Responsabilidades
• Bachelor's Degree or Equivalent in related field
• 5 years of experience in Medical Device Industry, Quality System, or clinical environment (cardiac care, ICU, OR, cardiovascular interventions)
• Moderate knowledge of cardiovascular imaging principles and concepts