Josue Silva

Experience

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  ZIMMER BIOMET MANUFACTURING, B.V

  Jan 2010 - Jan 2010

  Capstone project

  • Implementation and consolidation in Okuma Milling Machine Incorporating secondary processes for tibia nail manufacturing.• Improve the productivity by reducing process lead time, motion waste, inspection time, labor cost.

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  Merck Sharp & Dohme Animal Health, S.L

  Jan 2011 - Jan 2012

  Validation specialist

  • Coordinated construction, installation and startup of factory manufacturing building validation activities.• Primary responsibility includes the preparation of validation protocols (IQ/OQ, PQ) and commissioning documents for newly installed equipment and systems, as well as previously qualified equipment.• New product process development and sustaining product.• Development and execution of Installation Operational Protocols and Equipment Installation Reports.• Good manufacturing practices, and procedures related to quality control in the FDA regulated industry. Show less

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  Integra LifeSciences

  Apr 2015 - Dec 2021

  Validation Engineer

  • Hands-on experience in manufacturing medical devices, testing and in troubleshooting various medical devices.• Executing Equipment Qualifications (IQ), Process Validations (OQ/PQ), as well as Software Validations and Test Method Validations.• Performed test method validations (gage R&R studies - MINITAB)• Generate/updated manufacturing processes and documentation. Wrote IQ, OQ, PQ, Software installation and validation, and Engineering studies.• Familiar with Quality System Requirements (21 CFR 820, ISO 13485, and FDA regulatory compliance)• Authoring and implementing Engineering Change (ECO) & SOPs utilizing Agile PLM tool, managing• Reviews ECO's and routes to the appropriate departments for approval for updated drawings and the• appropriate documentation in the ERP system.• Conducting equipment and process validations (IQ, OQ, PQ) on various types of manufacturing equipment & processes.• Supporting activities associated with scrap reduction, Non-Conformance investigations, Corrective and Preventative Actions.• Identifying and leading cost saving efforts throughout the operation by improving manufacturing efficiency, implementing new technology, and analyzing/modifying workflow, space requirements, and equipment layout.• Provide support with BOM (Bill of Materials) and routings validation. • Design of experiment analyzed system design to develop efficient tests methods that generate objective evidences of Verification.• Remediation project for ISO11607• Support engineering by identifying material changes.• Working with the suppliers develop corrective action plans to correct any material change in quality and productivity.• Assist in all supplier qualification endeavors. Coordinate with Technical Support, Engineering, Manufacturing and technical Support to ensure awareness to known purchased part or product quality issues. Show less

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  Power Design, Inc.

  Dec 2021 - now

  Communicate with customers to define the project scope and build relationships.Analyze drawings and specifications to figure out labor, material, and time costs.• Identify situations that require clarification during the Bid process.• Review relevant data to determine cost of materials and requirements for labor.• Prepare cost estimates.• Request prices of lighting fixtures, lighting control, electrical gear, subcontractors, etc.• Conduct studies to develop effective cost reductions.• Continuously follow up on all bid projects and accurately forecast future awards/ probabilities.Assist in the execution and support of the construction processes (change orders.) Show less

  • Senior Estimator

    May 2024 - now

  • Estimator

    Mar 2023 - May 2024

  • Change order specialist

    Dec 2021 - Apr 2023