Operations leader with over 25 years of hands-on experience in Medical Devices (Class III and II) and Biologics Engineering and Manufacturing Operations. Held leadership positions as Senior Director of Engineering and Technology in Class III devices, Engineering Director in a vertically integrated Biotechnology Manufacturing Facility with ownership of Engineering, Maintenance, Metrology, Information Technology, Process Automation, Energy Management and Reliability Program. Previous Experience as Manufacturing Director of Medical Device manufacturing operation with over 1,200 employees. Operations including Extrusion, Injection Molding, Assemble, Packaging and Sterilization. Specialties: Reliability Centered Maintenance, Project Management, Asset Management, Cell Culture, Aseptic Filling, Lyophilization, Injection Molding, Extrusion, Device Assembly and Packaging and Device Sterilization.

Director II, Technical Services @ Responsible for Technical Services Organization at B Braun Medical in Irvine California. Areas of responsibility include Maintenance, Engineering, Project Management, Manufacturing Engineering, Controls Engineering and Critical Systems for a large volume device manufacturing operation. Overall facility size of over 750,000 square feet and close to 300 direct/indirect reports. From May 2015 to Present (8 months) Director II, Technical Services @ Responsible for Technical Services Organization at B Braun Medical in Irvine California. Areas of responsibility include Maintenance, Engineering, Project Management, Manufacturing Engineering, Controls Engineering and Critical Systems for a large volume device manufacturing operation. Overall facility size of over 750,000 square feet and close to 300 direct/indirect reports. From May 2015 to Present (8 months) Senior Director of Engineering and Technology @ Oversee Device Engineering and Technology function for Global Technical Operations in a Class III implant business. Manage portfolio of VIP and Line Extension Projects for Santa Barbara and Costa Rica plus Product Launch activities for New Product Introductions (NPI's). Liaison between R&D, design Development, Process Development and Manufacturing. Responsible for Tech Transfer and Design Transfers to Manufacturing operations in Costa Rica. Indirect responsibility for Process and Product Engineering function in manufacturing. Responsibility for Site Maintenance, Calibration and EHS. From November 2013 to Present (2 years 2 months) Director of Engineering @ Direct oversight of Engineering, Maintenance, Process Automation, Metrology, Information Technology, Reliability and Energy Management functions in a vertically integrated Biologics Manufacturing Facility. Responsible for $20MM yearly operation budget and Capital budget in excess of $10 MM per year. Direct support for 4 Bulk Manufacturing Suites, 2 Formulation areas plus 2 aseptic fill lines and packaging operations. Major Capital projects including Advate Bulk Manufacturing suite and expansion of Formulation and Filling complex including new formulation suite and 4 Commercial Lyophilizers. Construction and Validation of new modular cleanroom for biologics Combination Device. Automated assembly and VHP sterilization. From March 2005 to November 2013 (8 years 9 months) Director of Manufacturing @ Direct oversight of Manufacturing Operations for high volume Medical Device Manufacturing Facility. Supervision of 7 plus direct reports and over 750 indirect reports in a 7 day/24 hour operation including plastics extrusion, injection molding, high speed assembly, PVC and non PVC I.V. bags manufacturing and gamma sterilization. Managed a budget of over $20 MM and a Capital Budget of $2-3 MM annual. From March 2000 to March 2005 (5 years 1 month)

B.S. Biomedical Engineering, BioMechanics @ Case Western Reserve University From 1985 to 1988 B.S. Biology, BS Biology @ Catholic University of P.R. From 1982 to 1984 High School @ Colegio poncenoColegio ponceno Jaime Morales is skilled in: Manufacturing, Medical Devices, Aseptic Processing, Biotechnology, Engineering, Injection Molding, Cell Culture, Sterilization, Manufacturing Operations, Purification, Packaging, Extrusion, Formulation, Management, FDA