סקירה כללית
Pi-Cardia, a dynamic medical device startup specializing in cardiovascular innovations, is looking for Senior Research Engineer to join our Research team. This role drives Research and V&V activities across product development, from planning and executing tests to analyzing results and maintaining DHF documentation, ensuring products meet the highest quality and regulatory standards. You’ll collaborate closely with cross-functional teams and play a key role in advancing life-changing cardiovascular technologies. Responsibilities: * Lead V&V activities, including resource planning and test protocol creation * Analyze test results, investigate anomalies, and drive corrective actions with R&D and Quality teams * Maintain DHF documentation and ensure readiness for audits and inspections * Support complaint handling and failure investigations * Collaborate with QA/RA teams on regulatory submissions, providing V&V documentation and objective evidence * Plan and perform pre-clinical studies/research for new product indications Requirements: * 6+ years of experience in R&D / Research Engineering with strong involvement in Verification & Validation (V&V) in the medical device industry * BSc in Engineering or Sciences (Mechanical or Biomedical preferred) * Proven experience in defining and executing V&V strategies, including test planning, execution, analysis, and reporting * Strong understanding of the medical device development lifecycle and working under Design Controls (ISO 13485) * Hands-on experience with Design History File (DHF) deliverables and managing documentation for design changes * Knowledge of regulatory and quality requirements (FDA, EU MDR, ISO standards) and ability to apply them in V&V planning * Excellent documentation, communication, and cross-functional collaboration skills
דרישות המשרה
* Lead V&V activities, including resource planning and test protocol creation * Analyze test results, investigate anomalies, and drive corrective actions with R&D and Quality teams * Maintain DHF documentation and ensure readiness for audits and inspections * Support complaint handling and failure investigations * Collaborate with QA/RA teams on regulatory submissions, providing V&V documentation
