VP of Engineering

Vice President Of EngineeringWe 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 to enhance efficiency, reduce costs, and improve product quality. 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 throughout the production process. Lead investigations into deviations and non-conformances, ensuring thorough root cause analysis and effective corrective actions. Engineering Change Management Oversee the implementation of Engineering Change Orders (ECOs) across production lines and contractors. Ensure changes are executed with minimal disruption to production while maintaining product quality and regulatory compliance. Contractor Management and Supply Chain Optimization Qualify and manage contractors to ensure alignment with PixCell Medical's quality standards and production goals. Collaborate with Supply Chain to optimize supplier relationships and component sourcing. Continuous Improvement and Innovation Lead cost reduction initiatives without compromising product quality or performance. Drive process improvements to enhance manufacturing efficiency and product reliability. Collaborate with R&D to identify opportunities for product enhancements based on manufacturing insights. Deviation and Non-Conformance Management Establish and oversee a robust system for identifying, reporting, and investigating deviations and non-conformances. Lead root cause analysis efforts for critical and major deviations, utilizing tools such as 5-Why, Fishbone Diagrams, and Pareto Analysis. Implement data-driven approaches to trend analysis for identifying systemic issues and opportunities for improvement. Corrective and Preventive Action (CAPA) Management Develop and implement effective CAPA plans based on deviation and non-conformance investigations. Ensure timely closure of CAPA items and verify their effectiveness in preventing recurrence of issues. Foster a culture of continuous improvement and proactive problem-solving within the engineering team. Job Requirements:BSc. degree in Engineering (Manufacturing, Industrial, or Biomedical preferred). 10+ years of senior management experience in medical device manufacturing or related industries. Proven expertise in NPI processes, production optimization, and quality management systems. Strong knowledge of FDA regulations, ISO 13485, and experience maintaining 510(k) clearance. Demonstrated proficiency in lean manufacturing principles, Six Sigma methodologies, and statistical process control. Extensive experience in managing complex engineering projects and cross-functional teams. Strong background in root cause analysis, CAPA implementation, and quality improvement methodologies. Excellent communication and leadership skills, with the ability to influence at all levels of the organization. Key Performance IndicatorsSuccessful execution of NPI projects with seamless transitions from R&D to production. Improvement in key production metrics (e.g., yield, cycle time, cost reduction). Reduction in deviation and non-conformance rates through effective root cause analysis and CAPA implementation. Achievement of regulatory compliance standards and successful completion of audits. Development and execution of strategic initiatives leading to significant cost savings and efficiency improvements. Why Join PixCell Medical?As VP of Engineering at PixCell Medical, you will play a pivotal role in advancing our mission to revolutionize point-of-care diagnostics. You'll lead a talented team in optimizing manufacturing processes for groundbreaking medical devices while driving innovation in healthcare. This is an opportunity to make a tangible impact on global health by ensuring the reliable production of cutting-edge diagnostic tools. Join us in shaping the future of blood diagnostics and improving patient care worldwide!