Carlos José Muñiz Jiménez, P.E. Email and Phone Number

Oversee NGMBT (family of five medical device products) and QuikHeel processes: maintenance, troubleshooting, modifications and qualifications of automated production equipment; process and controls engineering support; yield improvement and uptime projects (several modular machines); optimize PMs; generate software change control and related testing/documentation and validation plan (coordination, testing and closing).•o NGMBTequipment improvements: validation, supplier coordination, change control, IQ, protocols and closing. o Installed a sensor w/PLC program to avoid dispenser crash mitigating losses up to $25K per incident. o Trained technicians on equipment adjustment procedures. o Implemented a verification process and visual aid to explain/recreate installations and labeled hoses by color to address as part of corrective and preventive actions• Performed engineering studies for automation systems: PLCs and vision inspection systems.• Offer technical guidance and support to maintenance technicians for troubleshooting automated production equipment including vision systems and PLCs. • Develop procedures for the operation, troubleshooting and preventive maintenance of automation equipment; trained maintenance technicians and setup operators.• Supported the achievement of site performance vs budget targets by managing capital projects effectively and ensuring accurate process volume/mix changes.• Provided technical expertise to QA in several investigations: CAPAs, changes in SOPs and training; aided in the reduction of customer complaints and nonconformance issues.• Contributed to safety compliance with protection equipment enforcement and incident investigations.

Member of the NGMBT engineering team, leading and participating in several validation activities improvement/characterization projects including Installation, Operation, and Performance qualifications for all five (5) product families of Microtainer Tubes with Microgard Closures. Supervise up to two contractors and one validations technician.• Led three technicians for improvement projects on automated manufacturing equipment, control systems and vision systems of the Life Sciences – Pre-Analytical Systems Division, to increase capacity and efficiency.• Provided technical support for projects. Supported, approved and executed equipment/process related validations following internal/external regulatory requirements, processes and procedures.• Supported manufacturing/production efforts for the NGMBT process.• Other projects: torque reduction to mitigate leakage; inclusion of product expiration date adhering with a new FDA rule.• Investigated and documented deviations in validation processes.

• Provide Controls engineering support for Roche’s AccuChek disposable reagent test strips production to provide accurate glucose readings. Responsibilities include gives technical support on control systems for manufacturing, troubleshooting process issues leading/contributing to process improvement/characterization projects; developing and reviewing manufacturing process documentation, training maintenance and production personnel; and conducting pilot and validation activities.• Implement improvement projects that improve quality, compliance, improve efficiencies, yields, or throughputs. Define root cause and implement solutions to equipment and process related non-conformances utilizing the NCR and CAPA processes. • Perform project management tasks for projects involving either new or existing equipment. Submitted Capital for approval, prepare schedule, find resources for my project.• Experience in the implementation of PLC, PC control systems, machine/system test and commissioning on high speed production equipment’s.• Being part of the Strip Lamination (SL) engineering team, participating on the various validation activities, improvement/characterization project like vendor acceptance test, coordinate the installation of the equipment on the site, and the Installation Qualification, Operation Qualification, Performance Qualification.• Lead or support improvement projects on manufacturing equipment, Control Systems and Vision Systems. • Provide technical support for projects. Support and/or develop and execute equipment or process related validations in accordance with Roche Diagnostic’s requirements, processes and procedures.

• Applies standard practices and techniques in situations, adjusts and correlates data, recognizes discrepancies in results, and follows operations through Coating processes to optimize performance. • Analyze situations or data and monitor or establish process controls to find answers and solutions of Cypher Coated Stent department manufacturing modules issues to increase yield and reduce downtime. • Being part as manufacturing engineer of a new Manufacturing Process development in order to extend the shelf life of a medical device providing guidelines of equipment behavior, correct execution of Protocol for IQ/OQ/PQ/PPQ/ICH, DOE’s and Engineering Studies; perform non-conformance investigation and/or deviation. Create and submitted to review and approval change request (CR) and document change request (DCR) of procedures to improve this new manufacturing process. • Prepare Technical Reports of Non-Conformance Investigations and Non-Conformance Corrections and Preventions actions for current manufacturing process and the new process in development at this moment. In addition, I review and approve technical Reports of Non-Conformance Investigations and Non-Conformance Corrections and Preventions actions for current manufacturing process as Engineering representative. • Performed IQ/OQ Computer System validations of equipment. • Provide direct support to Coating department manufacturing modules and personnel. Especially New Process development and New Product development modules. Analyze situations or data to make recommendations based on the manufacturer recommendation related to use, cleaning, installation of the equipment or the manufacturing processes, on the work center team (WCT) daily meetings that result on the continuous process improvement of the Coating department modules. Also provide support to Manufacturing & Engineering Technicians during the machinery equipment’s troubleshooting.

• Acted as technician for the transition of a modular production system from HP site on Corvallis, Oregon to Puerto Rico. • Performed alignments, adjustments, calibrations and tests associated with the installation, relocation or refurbishment of the equipment. Reviewed spare part data of the machinery.• Participated in a new module buy-off and teardown on D.W. Fritz Company in Portland, Oregon providing skilled technical maintenance assistance in the design, installation, debugging, and characterization of the new equipment. This high-tech module was sent to Puerto Rico. • Responsible to support, optimize, upgrade and maintain the computer network infrastructure of our line based on the Windows operating system environment.• Troubleshoot and repaired failures in very expensive and exclusive equipment through the applications of advanced technologies. • Worked in the implementation of plc logic and made use of different communication protocols like Data Highway, ControlNet, Ethernet and Remote I/O to modify and improve the equipment used to inject the ink in our cartridges.• Implemented preventive maintenance programs on a select group of equipment and determined priorities to minimize disruption of production/process.