Sara Aguirre

• Management of projects, including communication with internal customers, involving complex design or processes.
• Provide technical support to the manufacturing product lines.
• Identify and implement process improvements to increase efficiency and reduce costs.
  Develop and maintain manufacturing processes, work instructions, forms, BOMs, routers, FMEAs, DMRs, and other documents as required.
• Collaborate with cross-functional teams to ensure products are manufactured to specifications.
• Participates in product design and development activities, including Design for Manufacturability (DFM) reviews.
• Support process validation activities, including writing and/or performing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Develop and maintain equipment and tooling requirements, including purchasing and maintenance schedules.
• Support new product introductions and product transfers to ensure a smooth transition into manufacturing.
• Ensure compliance with all relevant regulatory requirements and industry standards.
• Evaluate quality control processes and make recommendations for improvements in quality control.
• Analyze production processes, schedules, methods, and other data and then provide management with reports containing the data and statistics to enable management to better understand future requirements needed for the manufacturing process.
• Review and calculate labor, material, and other production costs along with reviewing schedules and future production requirements to assist management in decision making.
• Analyze and plan workflow, equipment placement and space requirements to improve manufacturing efficiency.
• Coordinate equipment maintenance and repair services and make sure that manufacturer’s procedures and instructions are followed to keep production equipment operational.

Subject Matter Expert of Coating Process (AGB/AGB+ and CG+) & Chemical Lab.

Liaison Process Engineer for product transfer:

• AGB/AGB+, from Asheboro NC facility to Americas plant in Chihuahua, MX in 2014.
• CG+, from Reading PA facility to Americas plant in Chihuahua, MX in 2017.

Responsible for the following processes and activities within ISO class 7 & 8 cleanrooms:

• Catheter assembly, J-wire testing, Leak and Flow testing, and the Skiving process.
• Coating solutions preparation & Chemical lab testing.
• Final assembly of components on catheters.
• URS creation and FAT execution on the new equipment manufactured overseas.
• Creation and execution of validation documents (IQ/OQ/PQ) on equipment and processes such as: Mixing and Formulation Reactors for homemade solutions applied to Internal and External coating treatment. ITM Equipment / Internal coating process. AST Machines / External coating process. Hydrophilic coating machine and process. Leak and flow testing machine and process.
  QC Chemical Lab equipment (HPLC, mixers, Chemical fume hoods, PhMeter, Viscometer, Dryers, etc.)
• Creating SOPs, Work Instructions, and visual aids for processes and equipment.
• Operators training for process transfer and validations. Data and QC inspection verification as part of the validation process.
• Responsible for validations planning and execution, including raw materials, equipment, operators, etc., ensuring these resources were available on time.
• Problem-solving and process improvement in the Extrusions, Multilumen, Coating, and Packaging areas.
• Created, validated, and updated PFMEAS.
• Performed investigation for NCs and CAPA processes. Verified the validation status for operation processes as part of COFEPRIS requirements.
• Subject Matter Trainer. Process Control utilizing InfinityQS.
• Implementation of improvements for production machinery.
• Testing of new materials in all production areas.
• Process benchmarking with Czech Republic.
• 5’S project implementation.
• Execution of costs reduction projects.
• Worked as a point of contact with the Coating and Mutilumen R&D teams.
• Developed automation for the assembly process.
• Create an engineering study for aging time reduction on extrusions.

• Leading and organizing activities and schedules of metallurgists and technicians (14 people) to develop the daily work and the daily needs that arise in the mineral extraction process.
• Sampling points and monitoring KPI to meet gold and silver recovery according to the corporate budget. Applying corrective actions based on an investigation and root cause analysis.
• Development of test procedures and new research methods according to the needs of the process due to changes of mineral fed; report results to management staff for suggested changes and improvements to the process.
• Acidification, sedimentation, and leaching testing of copper in solids and solutions.
• Mineral and reagents determination and control in the extraction process

• Developed test procedures and techniques according to ISO 14644, United States Pharmacy (USP), and FDA applicable to the Medical industry.
• Creation of procedures and tracking process changes.
  Creation and documentation of protocols such as IQ, TQ, OQ, PQ, STM, and Gage R&R as part of validation transfer of a new process and lab test.
• Creation and implementation of work instructions, visual aids, and instructions for the set-up and calibration of equipment.
• Monthly management review by the management staff.
  Core team member of 9 kaizen events focusing on lead time reduction, increase of productivity, space release, and scrap reduction.
• 5`S Project into the laboratory work areas and Hoshin graphs to evaluate response times in different areas.
  Mapping lines and manufacturer practices in CEA for CAPA analysis and continuous improvement.
• Concentration, chemical structure (aldehydes), and activity testing of Heparin’s antithrombin (AT) binding sequence as critical for biological interactions with the blood.
• Material’s detection by Infrared Spectrometry (FTIR) and chemical stress testing. Process inspection in finished goods.
• Bioburden test in finished products and incoming components.
• Endotoxin detection test by turbidimetry method as incoming inspection in components and release criterion in finished products.
• Development and certification of growth media (TSA, PCA, fluids, and broths) for bioburden and sterility tests.
  Microbial identification in products and environmental monitoring.
• Sample preparation for dose audit to evaluate the external sterilization system. Sterility test in heart valves manufactured whit bovine tissue as a release criterion in the finished product.
• Controlled environmental areas (CEA) monitoring, particle counts, air, and superficial bioburden.
• Monitoring the water system (total Carbon, Bioburden, LAL, and conductivity water test), moist and oil detection in compressed air in every point of use inside CEA.
• Monitoring CEA’s temperature and pressure to maintain working conditions for workers and prevent contamination in products.

• Updating and releasing results for material receipt, line, and finished product through ICP analysis of heavy elements (Pb, Ba, Cr, Cd, As, Se, Sb, and Hg) in plastic parts, labels, paintings, softgoods, etc., ensuring free of contaminants toxic products.
• Testing flammability of finished product to evaluate the ignition risk and color migration tests in plastic parts.
• Development and execution of test procedures and methodologies according to international standards.