Eduardo Wolf

Experience

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  RM Industria Mecânica ltda

  Feb 2007 - Nov 2009

  Turning Operator

  Production Process:Experience in Production Process: turning / polishing / surface modification / miling / heat treatment / final inspection

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  Linea Ferramentaria ltda

  Nov 2009 - Jun 2011

  CNC Turning Operator

  Production Process:Experience in Production Process: turning / polishing / surface modification / miling / heat treatment / injection molding / final inspection

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  Meta Bio Industrial LTDA

  Jun 2011 - May 2013

  Project Assistant

  P&D Experience:• Design and development planning, Design and development inputs, Design and development outputs, Design and development review, Design and development verification, Design and development validation, Design and development transfer, Control of design and development changes, Design and development files.• Biomechanical analysis for Validation of Orthopedic Implants with the Finite Element Analysis (Nastran / Ansys / SolidWorks).• Mechanical Tests, worst case definition and sampling size in accordance with: ASTM F543/ ASTM F382 / ASTM F1264 / ASTM F1717 / ASTM F1378 / ASTM F1829 / ASTM F2028 / ASTM F1781 / ASTM F384 / ASTM F564 / ASTM F2180 / ASTM F1357 / ASTM F2887.• Risk Management for Medical Devices in accordance with ISO 14971.Chemical Process:• Passivation Validation (with compounding and buffering for nitric acid solution) for Orthopedic Implants in Implantable Stainless Steel ASTM F138 and ASTM F139.• Anodization Validation (with compounding and buffering for citric acid solution) for Orthopedic Implants in Titanium alloy ASTM F136 and Pure Titanium ASTM F67.• Passivation Validation (with compounding and buffering for nitric acid solution) for Orthopedic Implants in Cobalt Chromium alloy ASTM F75.Validation Process:• Casting Process Validation for Orthopedic Implants in Cobalt Chromium alloy ASTM F75 / ASTM F1537.• Heat Treatment Validation for Orthopedic Instruments in Non-Implantable Stainless Steel ASTM F899.• Cleaning Validation for Orthopedic Instruments in Non-Implantable Stainless Steel ASTM F899.• Biocompatibility Validation for Orthopedic Implants in Implantable Stainless Steel ASTM F138 and ASTM F139 in accordance with ISO 10993.• Biocompatibility Validation for Orthopedic Implants in Titanium alloy ASTM F136 and Pure Titanium ASTM F67 in accordance with ISO 10993.• Biocompatibility Validation for Orthopedic Implants in Cobalt Chromium alloy ASTM F75 / ASTM F1537 in accordance with ISO 10993. Show less

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  Beccaro Equipamentos Industriais

  May 2013 - Aug 2014

  Mechanical Designer

  P&D Experience: Design and development planning, Design and development inputs, Design and development outputs, Design and development review, Design and development verification, Design and development validation, Design and development transfer, Control of design and development changes, Design and development filesMechanical Tests for Machinery ManufacturerRisk Management for Machinery ManufacturerProduction Process:Technical Responsable for the Production Process: welding / turning / polishing / surface modification / laser tube cutting / stamping / miling / heat treatment / final inspectionQMS Process:ISO-9001 experience for Machinery Manufacturer Production ProcessNR-12 experience for Machinery Manufacturer Project and Development Show less

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  FUSIMAQ AUTOMAÇÃO

  Aug 2014 - Oct 2016

  Mechanical Designer

  P&D Experience:• Design and development planning, Design and development inputs, Design anddevelopment outputs, Design and development review, Design and developmentverification, Design and development validation, Design and development transfer, Controlof design and development changes, Design and development files.• Mechanical Tests for Machinery Manufacturer.• Risk Management for Machinery Manufacturer.Production Process:• Technical Responsable for the Production Process: welding / turning / polishing / surfacemodification / laser tube cutting / stamping / miling / heat treatment / final inspection.QMS Process:• ISO-9001 experience for Machinery Manufacturer Production Process.• NR-12 experience for Machinery Manufacturer Project and Development. Show less

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  Wolf Engenharia - Elementos Finitos “WolfCAE”

  Oct 2016 - Nov 2022

  Researcher

  Researcher Experience:• Development of methodologies and monitoring of biomechanical tests on orthopedicimplants in the laboratory, using Finite Element Analysis. For use by doctors in writingscientific articles and books (Research work developed in partnership with the companyTechimport Implantes and its orthopedic consultants, during the employment contract from2016-10 to 2022-11)

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  TechImport - Tecnologia em Implantes Ortopédicos

  Oct 2016 - Nov 2022

  Regulatory Affairs Process:Technical Report and Critical Analysis “State of Art” for mechanical tests results validation in accordance with available literature for ANVISA registerResponsable for the Preparation of Technical Reports and Responses to Adverse Events for CustomerFinite Element Analysis in Orthopedic Implants for worst case definition for Mechanical Tests in-vitroProduction Process:Technical Responsable for the Production Process: casting / welding / turning / polishing / laser tube cutting / stamping / miling / heat treatment / 3D printing metal / cleaning / packaging and labelling / final inspectionQMS Process:Internal Auditor ISO 13485 (semestral)Quality Procedures experience in accordance with RDC-665 and ISO 13485 Show less P&D Experience: Design and development planning, inputs, outputs, review, verification, validation, transfer, Control of design and development changes, Design and development filesBiomechanical analysis for Validation of Orthopedic Implants with the Finite Element Analysis (Nastran / Ansys / SolidWorks)Mechanical Tests, worst case definition and sampling size in accordance with: ASTM F543 / ASTM F382 / ASTM F1264 / ASTM F1378 / ASTM F1829 / ASTM F2028 / ASTM F1781 / ASTM F564Risk Management for Medical Devices in accordance with ISO 14971Clinical Evaluation for Orthopedic Implants in accordance with Meddev 2.7/1 revision 4Chemical Process:Passivation Validation for Orthopedic Implants in Implantable Stainless Steel ASTM F138 and ASTM F139Anodization Validation for Orthopedic Implants in Titanium alloy ASTM F136 and Pure Titanium ASTM F67Passivation Validation for Orthopedic Implants in Cobalt Chromium alloy ASTM F75Validation Process:Cleaning Validation for Orthopedic Implants in Titanium alloy ASTM F136, Pure Titanium ASTM F67 and Cobalt Chromium alloy ASTM F1537Ethylene Oxide Sterilization Validation for Orthopedic Implants in Implantable Stainless Steel ASTM F138, ASTM F139, Titanium alloy ASTM F136 and Pure Titanium ASTM F67 and Cobalt Chromium alloy ASTM F75 / ASTM F153, in accordance with ISO 11135Packaging Validation for Sterile an Non-Sterile Implant and Instrument in accordance with ISO 11607Autoclave sterilization Validation for Orthopedic Implants in accordance with ISO 14937MRI Validation for Orthopedic Implants in accordance with ASTM F2119 / ASTM F2182 / ASTM F2052 and ASTM F2213Biocompatibility Validation for Orthopedic Implants in accordance with ISO 10993DLC coating Validation for Orthopedic Instruments in Non-Implantable Stainless SteelZirconia coating Validation for Orthopedic Instruments in Non-Implantable Stainless SteelDiamond coating Validation for Orthopedic Instruments in Non-Implantable Stainless Steel Show less

  • Technical Manager

    Jun 2017 - Nov 2022

  • Research and Development Project Manager

    Oct 2016 - Nov 2022
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  ABNT - Associação Brasileira de Normas Técnicas

  Jan 2022 - now

  • Committee member CE 026:070.015 - Implants for Surgery

    Jan 2022 - now

  • Committee member CE 026:070.001 - Implant Materials

    Jan 2022 - now

  • Committee member CE 026:130.001 - Biological and Clinical Evaluation of Medical Devices

    Jan 2022 - now

  • Committee member CE 026:070.004 - Implants for Joint and Bone Replacement

    Jan 2022 - now

  • Committee member CE 026:070.005 - Implants for Osteosynthesis and Spine

    Jan 2022 - now
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  DNV Product Assurance AS

  Nov 2022 - now

  Technical Assessor

  Technical Assessor Experience:• Ensuring Medical Devices (orthopaedic implants, in particular) are safe to enter and remainin the EU market. Codes:• MDN 1102 Non-Active osteo and Orthopaedic Implants• MDN 1103-1 Non-Active Dental Implants• MDN 1208 Non-Active Non-Implantable Instruments• MD 0106 Non-Active Instruments• MD 0202 Non-Active Orthopaedic Implants• MD 0401 Non-Active Dental Equipment and Instruments• MD 0403 Dental ImplantsAuditor Experience:• Ensuring that the Medical Devices Manufacturer´s QMS of the are in compliance with ISO13485, MDD and EU 2017/745 MDR. Codes:• MDN 1102 Non-Active osteo and Orthopaedic Implants• MDN 1103-1 Non-Active Dental Implants• MDN 1208 Non-Active Non-Implantable Instruments• MDT 2001 Metal Processing• MDT 2002 Plastic Processing• MDT 2006 Chemical Processing• MDT 2011 Packaging, including Labelling• MD 0106 Non-Active Instruments• MD 0202 Non-Active Orthopaedic Implants• MD 0401 Non-Active Dental Equipment and Instruments• MD 0403 Dental Implants Show less

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  Claretiano - Rede de Educação

  Aug 2023 - now

  Teacher

  Teacher Experience:• Teacher of the Mechanical Engineering course, working in the discipline of Finite Element Analysis and Industrial Maintenance• Project Advisor BAJA (Car racing, Project Management and Competition)