Saulo Montero

Experience

• 

  Hospira

  Jun 2011 - Mar 2017

  Ensure compliance with all regulations and procedures in the Controlled Manufacturing Area. Represent Manufacturing department on internal and external audits (FDA, BSI, TUV, Corporate, etc.). Develop, write, and implement effective policies and procedures. Provide interpretation and training on policies and procedures to manufacturing personnel. Direct all manufacturing processes of the products. Assure proper operation of all equipment involved in the manufacturing process and the conversion of raw materials into high quality finished product. Represent Manufacturing department in Management, Quality, and Non-Conformance Reviews meetings. • Zero Observations on FDA & BSI Audits obtained• Satisfactory results on P&PC Internal Audit Obtained• Worked on UDI project implementation as Manufacturing Department representative• Leaded Manufacturing Cart Replacement project to improve product quality• Voluntary Protection Program (VPP) manufacturing leader Show less Efficiently manage assigned resources (200+ people, material, equipment, infrastructure, etc.) to ensure high quality products are delivered to the clients at the lowest cost possible. Plan and project production schedule in order to comply all the metrics (KPIs) of the assigned production lines. Ensure Good Manufacturing Practices, Procedures and Policies are followed by assigned personnel. Lead continuous improvement project. Lead daily huddles with multi-functional team in order to solve any issue that could be affecting the line.• Kept all line’s metrics (Schedule Adherence, Material Variance, Efficiency, Etc.) within the target• Phase II’s Leader Supervisor (6 manufacturing lines at this stage): coordination of Phase II’s activities with Plant Management Show less Lead improvement, cost reduction and cost avoidance projects. Implement and manage Lean tools such as: suggestions/kaizen program, visual management, continuous flow, One-Piece flow, SMED, Pull System, Kanban, Jidoka, 5S, SPC, Heijunka, Kamishibai, Skill Matrix, etc. Performed root cause analysis using 5 why, PDCA, DOE, Is-Is Not and 8D methodologies to take actions that eliminates the root cause of the problem. Kaizen events execution in many processes. KPIs management. Provide training to plant personnel on Lean principles and Lean culture. Lean Academy Teacher. Suggestion program management.• Leaded One-Piece Flow Project for tree (3) manufacturing lines• Cost reduction and savings exceeding US$ 600,000.00 per year• Receptal area Lean Coach• Worked on implementation of all continuous improvement system (HPS) Show less

  • Regulatory Production Supervisor

    Jul 2015 - Mar 2017

  • Production Supervisor

    Mar 2014 - Jul 2015

  • Continuous Improvement Technician

    Apr 2012 - Jul 2014

  • Manufacturing Quality Technician

    Jun 2011 - Mar 2012
• 

  Medtronic

  Mar 2017 - now

  Production System Engenieer

  • Opex Manager - Advance Surgical Instruments and Neuroscience

    May 2023 - now

  • Site Industrial Engineering Manager

    May 2022 - May 2023

  • Opex Manager (Interim)

    May 2021 - May 2022

  • Sr. Opex Engineer

    Nov 2019 - May 2021

  • Production System Engineer (Industrial Engineer) | Opex

    Mar 2017 - Nov 2019