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We are seeking an exceptional Vice President of Engineering to lead our engineering activities, focusing on New Product Introduction (NPI), production optimization, and continuous improvement. This role is critical in translating R&D innovations into scalable, high-quality manufacturing processes for our HemoScreen analyzer and disposable cartridges.Key Responsibilities:New Product Introduction (NPI) and Production Transfer: Spearhead the transition of R&D outputs into robust, scalable production processes; collaborate with R&D, Quality Assurance, and Manufacturing to ensure seamless product transfers; implement Design for Manufacturing (DFM) principles to optimize product designs for production.Production Support and Optimization: Oversee the design, documentation, and implementation of production jigs, machinery, and processes; drive lean manufacturing initiatives; develop and execute comprehensive training programs for production staff.Quality Management and Compliance: Ensure strict adherence to FDA regulations and maintain 510(k) clearance for the HemoScreen analyzer; implement and oversee robust quality control systems; lead investigations into deviations and non-conformances with thorough root cause analysis and corrective actions.Engineering Change Management: Oversee the implementation of ECOs across production lines and contractors, ensuring minimal disruption and regulatory compliance.Contractor Management and Supply Chain Optimization: Qualify and manage contractors; collaborate with Supply Chain to optimize supplier relationships and component sourcing.Continuous Improvement and Innovation: Lead cost reduction initiatives; drive process improvements; collaborate with R&D on product enhancements based on manufacturing insights.Deviation and Non-Conformance Management: Establish and oversee systems for identifying, reporting, and investigating deviations; lead root cause analysis (5-Why, Fishbone, Pareto); use data-driven trend analysis.Corrective and Preventive Action (CAPA) Management: Develop and implement effective CAPA plans; ensure timely closure and verify effectiveness; foster a culture of continuous improvement.Job Requirements: BSc. in Engineering (Manufacturing, Industrial, or Biomedical preferred); 10+ years senior management in medical device manufacturing or related; expertise in NPI, production optimization, QMS; strong knowledge of FDA regulations, ISO 13485, and 510(k); proficiency in lean, Six Sigma, SPC; experience managing complex engineering projects and cross-functional teams; strong background in root cause analysis and CAPA; excellent communication and leadership skills.Key Performance Indicators: Successful NPI execution and transfers; improvement in production metrics (yield, cycle time, cost); reduced deviation and non-conformance rates; regulatory compliance and audit success; strategic initiatives delivering cost savings and efficiency.Why Join PixCell Medical? Play a pivotal role in advancing point-of-care diagnostics, leading a talented team to optimize manufacturing for groundbreaking medical devices, making a tangible impact on global health.