Eber Gonzalez

Experience

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  Medtronic

  Jul 2010 - Jun 2015

  Manufacturing engineer

  Responsible of Engineering function giving continual support to Production and R&D areas. Assure that product is compatible with the costumer design and requirements developing efficient, safe and cost feasible manufacturing processes following the established procedures and standards.• Support to manufacturing lines, improvement on processes, line balancing and scrap control.• Heart Valves Mitral & Aortic/Annuloplasty Rings and Bands Products• Product Transfer.• Engineering change orders.• CAD design (Solidworks/Autocad).• Equipment/machinery implementation, tooling and fixtures design and documentation.• Standard work sheets, manufacturing work instructions.• Project leadership to meet continuous improvement goals.• Creation and improvement of BOM’s and routings.• Lean tools: 5s, DMAIC, VSM, flow pull, problem solving, kaizen, Six sigma. Green Belt Training.• Product/equipment/tooling validation IQ, OQ, PQ, NCMRs, Complaints, CAPA.• ISO13485/GMP's/FDA CFR 21• SAP MRPMajor Achievements:• Contour 3D medical product transfer.• Repair Products Stability Project leadership, Kaizen event and application of DEMAIC tooling, achieving MOS stability, reducing space 800sq ft to 600sq ft, productivity improvement from 60% to 78%.• Improvement of Duran pneumatic fixtures reducing scrap in 50% from an average 3.30$ to 1.56$ per hour Show less

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  Sensata Technologies

  Jun 2015 - Jun 2016

  Manufacturing Engineer

  Responsible Engineer for Product Transfer/New product introduction support-Process/Quality improvement (tooling, equipment, balancing, times studies, poka yoke, layout changes)-Sustaining to production, Rotary/Linear Position Sensors-Product transfer (BOMS/Routings, drawings, tooling, equipment, documentation)-Work Instructions, Procedures, Visual Aids-CAD, fixtures/tooling design-JDE Edwards MRP SYSTEM-AS 9100Major Achievements: Successful transfer product of rotary pots and linear pots lines (automotive/aerospace position sensors) from Goleta CA to Sensata Otay (10 family products). Improvement and introduction of new layouts, process flows, new equipment, tooling and fixtures. Training support/training matrix/operator’s certification. Show less

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  Össur

  Jun 2016 - May 2021

  Working at Ossur Tijuana plant on DGS division (hearing aids manufacturing) ITE/Moulds Custom and ITE reconditioning areas.Lead of a multidisciplinary team of 3 Engineers, 1 Engineering tech. and 2 Maintenance technicians focusing on:- Process sustaining and product support on Custom area- New products introduction, process verification and PPA’s.- Process improvements through PSP projects- Manufacturing equipment and software support- Adapt acoustical support- Equipment maintenance- Calibration and Validation approach.- MDSAP / TUV compliance- Project transfers Show less First manufacturing engineer on DGS Mexico responsible for process sustaining and project improvements contributing together with Quality team the compliance on ISO13485/MDSAP-Process Sustaining Hearing Aids ITE/BTE Moulds Manufacturing-Lean Manufacturing Projects (cell systems, flow-pull, one piece flow implementation)-Product Transfer-Process improvement (RTY, FPQ, Scrap Rate)-Fixtures, Go no go's, tooling/equipment support/installation-Reworks improvement projects-Layout changes-Process/equipment qualifications, validations (MVP, Schedule, IQ, OQ, PQ, reduced IQ-OQ)-MWI's, Visual Aids, Training.-Root causes investigation, preventive-corrective actions.-Equipment implementation & maintenance (hearing aids manufacturing equipment)-Internal Auditor ISO13485:2016Major achievements:• Oticon ITE Repair Product transfer.• Creation of Rework flow system contributing to keep TAT 5 Days on 95%.• Problem Solving Process (PSP) project for Reworks on ITE area achieving a rework rate monthly decrease from 42% to 25%.• Creation of Scrap rate system on ITE/PM area, improving from 6.00$ to 3.5$ per hour. Show less

  • Engineering Coordinator

    Jul 2020 - May 2021

  • Manufacturing Engineer

    Jun 2016 - Jul 2020
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  Demant

  May 2021 - now

  As individual contributor currently leading 4 strategic projects from Mexico side:• BTE Service/BTE Moulds transfer (Product, Process and ERP system aspects)• Magneto Chargers RCON transfer (leading all technical aspects from MX) • DC expansion from Standard area (Project divided on 4 phases of layout changes, including warehouse and DC process mapping, capacity calculation, HC, storage space, equipment, ERP software and quotations required for new incoming projects) • New packing area on Custom area warehouse. (Design and proposal of process with 16 new stations, considering process capacities, equipment, ERP software, HC, training, quotations, and business case.) Show less (Employing over 20,000 people, Demant is a world-leading hearing healthcare group that offers solutions and services to help people with hearing loss, competing with the biggest companies around the world. Demant Operations Mexico is the second largest manufacturing HUB in the company).Lead of a multidisciplinary team of 7 Engineers, 1 Engineering tech. and 2 Maintenance technicians focusing on:- Process sustaining and product support on Custom and Std. areas- New products introduction, process verification and PPA’s.- Process improvements through PSP projects following Demant GMS methodology.- Manufacturing equipment and software support- Adapt acoustical support- Equipment maintenance- Calibration and Validation approach.- MDSAP / TUV compliance- Project transfersMajor Achievements:• On time successful transfer of Custom Production and Warehouse from Ossur Mexico to Demant Ops new facility (part of Carmen Project). Planning, execution and technical contribution on layout design and production flows. Workstations and lines design, utilities calculation for each production process flow for Custom area. Leading a multidisciplinary team of 2 engineers, 3 technicians and 10 operators for transfer execution, installation, documentation, and validation. Show less

  • Project Manager

    Dec 2024 - now

  • Engineering Project Coordinator

    Jan 2023 - Dec 2024

  • Engineering Coordinator

    May 2021 - Jan 2023