V&V Manager

• Leads all company activities related to Verification and Validation of new products, as well as related instrumentation and their handling. • Defines, supervises and executes V&V masterplan for products and bench tests, in order to ensure product compliance with applicable regulatory standards. • Professional responsibility over BioAnalytics in the company. Duties and Responsibilities • Prepares V&V protocols and reports throughout product lifecycle (URS, PRS, Design Reviews, final product design validation tests). • Manages V&V team, including engineers, technicians and students, as well as their professional training and supervision. • Has overall responsibility for company’s Risk Management process. • Defines and writes testing work instructions. • Supports engineering, manufacturing and QC activities, participates in ECO and MRB processes. • Defines requirements for testing and inspection setups. • Manages third party testing and validation activities. • Works closely with other R&D, QA, Regulatory and product team leaders
דרישות התפקיד
• Education - B.Sc. equivalent or higher, Biomedical Engineering. • At least 5 years of experience in V&V of medical devices. • Very high interpersonal skills. • Excellent technical writing skills (English and Hebrew). Advantages • Experience in orthopedic products • Experience in a QMS environment • Familiarity with ISO 13485 • Managerial experience The position is full-time