- מיקום
- כל הארץ
- היקף משרה
- משרה מלאה
- תפקיד
- דאטה סיינטיסט
תיאור המשרה
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 %28V&V%29 in the medical device industry
- BSc in Engineering or Sciences %28Mechanical or Biomedical preferred%29
- 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 %28ISO 13485%29
- Hands-on experience with Design History File %28DHF%29 deliverables and managing documentation for design changes
- Knowledge of regulatory and quality requirements %28FDA, EU MDR, ISO standards%29 and ability to apply them in V&V planning
- Excellent documentation, communication, and cross-functional collaboration skills
