Karla Navarrete

Experience

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  3D Robotics

  Jun 2014 - Feb 2015

  PRACTICANTE
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  Benchmark Electronics, Inc.

  Apr 2015 - Aug 2019

  Ingeniero

  Strong understanding of cables and harnesses manufacturing processes such as preparation, crimping, soldering, harnessing, potting, assembly and packaging. Basic knowledge of injection molding, SMT, wave solder and conformal coating.• Experienced in process design, plant operations, logistics, risk mitigation and cycle time reduction. • Creation of Gantt charts, work breakdown structures, and technical report generation for management. • Outstanding communication, problem-solving, and relationship-management skills.• Implemented Just-in-Time (JIT)• New Products Introduction: Quotations, Manufacturing Process Flow, work instructions.• Develop First Article Process, pilot run.• Develop Lay-out elaboration• Develop instruction sheets and visual aids • Process Improvements, Engineering Changes internal and external (ECOs) • Design of fixtures and templates• Quote and purchase of new equipment• Time study and movements, Standardization y Line balancing.• Support Kanban implementation Show less

• 

  Corza Medical

  Aug 2019 - now

  Development engineer focused on the creation or improvement of the design of medical products and processes, with experience in regulations and standards for the design of medical devices. • Lead activities as project owner• Shipping and monitoring of tests to external laboratories• purchases of materials and follow-ups with suppliers• Development and validation of new products, control Documents *Design and development project plan (DDPP) *Item Master Forms (IMF) * Design history File (DHF) *Procedures creation (PD’s) *Validation Master Plan (VMP) *Device Master Record (DMR) *Quality Plans (QP) *Design Review Summary (DRS) * IQ, OQ, PQ Validation * Engineering Study (ES) * Aging Study * Transport Study Show less Strong understanding in sutures and needles, and their derived processes (Spooling, Barbing, cutting, welding, tipping, attaching, wrapping, sealing, ETO and Gamma sterilization, labeling and packing).• Line extensions, New line extension, introduction *Flowchart, PFMEA’s and Control Plans * Labeling Creation/Modification• Execution of protocols and reports, Installation qualification (IQ), Operational qualification (OQ) and Performance Qualification (PQ).• Engineering studies execution (statistics in minitab)• Execution and development of change requests (CRs) • Production capacity studies (Cp-Cpk-PPk) Minitab• Project execution under Microsoft project system• BOMS and ROUTES updates in (AX) system.• Specification update in Egon system.• Troubleshooting on the production floor (redlines, issues with shop orders, route issues, labeling issues etc).• High experience about development and execution of non-conformities (NCs), Failure Mode Investigation• Development and execution of rework plans (RWKs Form).• Part of MUV team, Data Analysis and Trend Evaluation.• Projects and plan’s for Cost Reduction• Statistical Process Control (SPC).• Project execution • DOE / Engineering Evaluation Show less

  • Product Development Supervisor - OEM

    Jul 2023 - now

  • Sr. product development engineer

    Aug 2022 - Jul 2023

  • Product Development Engineer

    Sept 2021 - Aug 2022

  • Manufacturing/Validation Engineer

    Aug 2019 - Aug 2022