דרישות התפקיד וניסיון נדרש:
* B.Sc. in Biomedical, Mechanical, Materials Engineering or a related engineering field. * 5+ years of QA / Quality Engineering experience in medical devices. * Strong, practical understanding of design controls and risk management. * Experience with verification & validation and test method development. * Hands-on experience with EO sterilization validation and sterile barrier systems. * Clear communicator, detail-oriented, proactive, and solution-driven. * Excellent documentation ability. * Ability to work in dynamic and multi-interfaced surroundings, micro and macro vision. * Ability to manage time and priorities and work under pressure. * English - high level (both written and spoken). * Excellent leadership and people management skills. * Service oriented. Nice to Have: * Experience with neurovascular products or Class III medical devices. * Familiarity with ISO 10993, sterilization, packaging validation, and regulatory submissions.
