Responsible for manufacturing engineering activities, corrective and preventative actions related to manufacturing non-conformances / issues, documentation, cost reduction, interface with engineering, quality, product management and, service, and training of manufacturing personnel. Supports LEAN culture focusing on standardization, quality, improved performance and increased throughput.Investigate and solve manufacturing issues related to biological detection products as they occur; implement corrective and preventative actions.Champion LEAN culture and continuous improvement initiatives. Supports CI events to ensure that improvements are captured, implemented and sustained.Create and maintain manufacturing job test procedures, work instructions, and master process documents.Design manufacturing fixtures and prototypes as required.Develop process and test protocols for automated equipment and manual processes.Establish and maintain routings, control BOM changes, and maintain BOM configuration dates.Maintain master material data for all manufactured products.Drive cost reduction projects to meet requirements of Value Engineering initiatives.Perform validation testing on new products and changes to existing products.Primary liaison with Development and Engineering teams on new products and engineering issues.Responsible for seeing that engineering changes are validated and implemented in manufacturing.Lead continuous improvement of cell culture-based production of biosensors for uniform performance and cost reductionsDevelop and implement quality standards and perform QC tests for biosensors and other reagentsDevelop and conduct reagent stability studies and validationsLead material requirements planning and inventory management for all biosensor-related parts.Drive cell banking production process for all current and new biosensor cell lines.Maintain all site equipment certifications and preventative maintenancesDevelop, improve, and implement cGMP practices in biotechnology lab settingsComplies with and ensures department compliance with all Company, policies and procedures.
