Manage and mentor a growing V V team, fostering a culture of quality, accountability, and continuous improvement.Define and lead the V V strategy, master plans, and schedules aligned to product development cycles and regulatory requirements. Coordinate V V activities with external testing laboratories and vendors to ensure high-quality and timely deliverables.
Champion continuous improvement of V V tools, methodologies, and infrastructure
Oversee and execute verification and validation activities, including protocol design, testing, and ation for capital systems and disposable devices.
Ensure robust TEST method development, validation, and equipment qualification in accordance with industry and regulatory standards.Drive readiness for regulatory submissions and audits through comprehensive V V ation and compliance.Partner closely with R D, Quality Assurance, Regulatory Affairs,
Requirements: Bachelors or Masters degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related technical field.
Minimum of 5 years of progressive experience as a V V manager within the medical device industry
Proven experience in leadership or management roles.
Proven ability to build and scale V V infrastructure or teams
Demonstrated expertise in capital equipment and disposable device testing, including system -level and component-level V V.
Familiarity with software validation and automated TEST systems.
In-depth knowledge of design controls, risk management, and regulatory frameworks(FDA, ISO 13485, ISO 14971, IEC 60601, EU MDR).Proficiency in TEST method development, statistical analysis, and TEST method validation (TMV).Strong leadership, project management, and cross-functional collaboration
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