Osvaldo Gonzalez

Osvaldo Gonzalez Email and Phone Number

Head of Operations @ Johnson & Johnson
United States
Osvaldo Gonzalez's Location
United States, United States
Osvaldo Gonzalez's Contact Details

Osvaldo Gonzalez work email

Osvaldo Gonzalez personal email

About Osvaldo Gonzalez

Mechanical Engineer with over 20 years of experience in manufacturing, design, equipment maintenance and troubleshooting, process improvements, validations, and product transfers.• Improve equipment performance by troubleshooting, repairing and redesigning as well as completely restructure the Preventive Maintenance and Calibration program to close CAPA audit observations.• Multiple successful manufacturing lines and product transfers.• R&D prototype manufacturing lines ramp up to an FDA-approved product manufacturing line.• Full decommissioning of cleanrooms manufacturing line, R&D Lab, Quality Lab, Laboratory and building site closure.• Develop customized equipment and tools for various projects (Medical Devices, Aerospace, Automotive). Proficient in multiple CAD software and manufacturing technologies.

Osvaldo Gonzalez's Current Company Details
Johnson & Johnson

Johnson & Johnson

View
Head of Operations
United States
Website:
jnj.com
Employees:
100890
Osvaldo Gonzalez Work Experience Details
  • Johnson & Johnson
    Head Of Operations
    Johnson & Johnson
    United States
  • Johnson & Johnson
    Site Lead / Npi And Operations Manager
    Johnson & Johnson Aug 2023 - Present
    New Brunswick, Nj, Us
  • Depuy Synthes
    Manufacturing Engineer Manager
    Depuy Synthes Jan 2023 - Jan 2024
    Raynham, Ma, Us
    • Manage the Engineers and Technicians teams, responsible for the complete direction and evaluation of the team’s work.• Direct the team according to the applicable policies and laws.• Interview, hire and train employees, plan, assign and direct their work, monitor their development, reward and discipline employees, assign complaints and solve conflicts.• Responsible for communicating business-related issues or opportunities to the next management level.• Responsible for ensuring direct reports are following all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.• Responsible for ensuring personnel and Company compliance with all International, Federal, State, local and Company regulations, requirements, policies, and procedures.• Procure and oversee outside vendors and consultants as required.• Manage projects associated with industrial design, new facility layouts, facility upgrades, and design and installation of new production and material handling equipment, process improvements, cost containments, yield improvements, and scrap reduction.• Oversee the Manufacturing Line Transfers and site Decommission projects.
  • Depuy Synthes
    Staff Manufacturing Engineer
    Depuy Synthes Jan 2017 - Dec 2022
    Raynham, Ma, Us
    • Engineering Lead of full manufacturing line transfers of medical devices from Codman (San Jose, CA) and Pulsar (Los Gatos, CA) to the new site at Cerenovus (Fremont, CA). Including Cleanroom, IQC, Laboratory, Packaging area and Spare Parts room. [2019-2020]• Equipment and Process Engineering Lead of the full manufacturing line transfer from Cerenovus (Fremont, CA) to Jabil (Tijuana, MX). Support the Manufacturing Line ramp-up at Jabil. Full Decommissioning of the Cerenovus site (Fremont, CA). [2021-2022]• Project Manager of the new Product Transfer from Cerenovus Fremont CA to Juarez, MX and Tijuana, MX. [2022-2023]• Site Assets manager. Support assets audits, FMV, end of life, Book Values and budget.• Lean Manufacturing, 5S, Robust Process and Process Improvement project team member.• Develop new tools, fixtures or solutions for Process Improvement, 5S, Ergonomics and Lean Manufacturing implementation.• Engineering Lead: manage work, projects and results from contract engineers and engineering technicians.• Track and lead project action items and ensure completion on multifunctional projects.• Supported Audit Observations as well as NCs and CAPA.• Equipment Readiness: Drawings, Equipment Specifications, Spares, Calibration and PM specifications.• Equipment and process improvement. Evaluate equipment and fixture, redesign and improve.• Review and update equipment, tools and fixtures drawings in SolidWorks CAD software. Release new drawings and drawing changes in the J&J document control system.• Perform Equipment and Process Validations.• Support New Product Introductions and Process Development.• Creator of the Technology Innovation Lab (Layout, Research for Technology, Purchase, and Implementation) for Process Development using 3D-Printing, 3D-Scanning and Smart Workstations.• Fast Prototyping development using SolidWorks with 3D-Printing and 3D-Scanning technology.• Capital Projects management and Project and Portfolio Management (Planisware).
  • Calibra Medical, Inc.  (Johnson & Johnson)
    Senior Manufacturing Engineer
    Calibra Medical, Inc. (Johnson & Johnson) Oct 2014 - Dec 2016
    • Converted R&D manufacturing equipment to Product Manufacturing line by creating related documentation and performing equipment and process validation meeting all FDA regulations.• Manufacturing equipment support and troubleshooting: Thermal Welding, Vision Systems, Laser Welding, Heat Stacking Welding, Vacuum Testing, Packaging Tray Sealers, Fluid Dispensers (EFD).• Equipment and tooling Decommissioning Management of the Calibra Medical (Manufacturing Line, R&D, Quality, Laboratory). Preformed closing PMs and Calibration. Obsoleted all equipment and process related documentation. Removed all equipment, tooling, fixtures. Crated and transfer to other locations (USA and Puerto Rico). Created quality equipment decommissioning plan and report. Close and ensure the building was fully empty and meet all requirements as per regulatory and landlord.• Managed Preventive Maintenance program and performed equipment maintenance.• Managed Calibration program and coordinate all external calibration activities.• Continuous improvement of technology/processes and utilized statistical tools to develop and execute validation protocols (IQ, OQ, PQ, TMV).• Addressed Quality, Technical, and Manufacturing issues (Audit Actions, NCR’s, CAPA’s, etc.).• Supported Facilities/Utilities (Cleanroom, Compress Air, HVAC, Pest Control, HEPA filters).• Managed Spare Parts inventory and evaluated required equipment Spare Parts to meet zero equipment breakdown.• Designed, procured, installed and troubleshoot assembly equipment, tooling/fixtures on all areas (Quality, R&D, Manufacturing), (Using SolidWorks).• Provided documentation & specifications for process & equipment including calibration specifications, drawings, process specifications, and work instructions.• Assigned PM and Calibration identification for all equipment, tooling and fixture as well as keeping track of all equipment activities, locations and repair. Use this data to create quarterly management reports.
  • St. Jude Medical
    Senior Process Development Engineer
    St. Jude Medical Jul 2013 - Jun 2014
    St. Paul, Minnesota, Us
    • Led product introduction activities during planning, implementation and launch phases (NPI - New Product Introduction). Accountable to generate, approve and change manufacturing documents to implement new processes and methods.• Performed full product transfers from other SJM facilities. Performed equipment transfer, installation and troubleshooting. Integrated Remediation activities as part of the product transfer. Quoted tools and equipment and follow-up suppliers. Supported materials department in order to incorporate all related materials on the PR facility.• Generated MVP, IQ, OQ, PQ and PPQ protocols and reports as well as execution. Use statistical analysis to evaluate validation data. Perform IMV, TMV and Gage R&R in order to comply with quality requirements.• Designed, developed and integrated new equipment at hardware and software level. In charge of equipment, product /process qualifications and approval.• Reviewed and monitored results of non-conforming product to identify causes. Implemented controls to eliminate causes, and assesses the success of the controls. Developed process improvements to achieve or exceed established goals.• Accountable for the direct supervision of engineers and/or engineering technicians during the product transfer. Accountable for projects cost and financial analysis.
  • Pall Life Sciences
    Product Engineer Ii
    Pall Life Sciences Feb 2012 - Jun 2013
    Port Washington, New York, Us
    • Single Use System (SUS) product design and manufacturing support.• Supported new products, process, machinery/equipment, part numbers and manufacturing (NPI - New Product Introduction).• Created customized product in 3D and 2D modeling using CAD Software (Autocad Inventor).• Used Statistical and Six Sigma concepts (DMAIC, RCA) to troubleshoot non-conformances, identify root cause and implement action plan. Kaizen implementation projects and 5S Methodology project support.• Monitored and improved manufacturing performance using LEAN principles including but not limited to SQDIP, standard work, Takt time, kanban, push/pull point of use.• Reviewed and approved documentation of the Kaizen team to improve documentation quality.• Implemented novel equipment, process and techniques to improve manufacturing and increase production capacity without sacrificing quality. One Piece Flow (OPF) process implementation.• Interacted with suppliers, customers and sales representative to provide a high quality customer oriented service.• Prepared and reviewed documents to support operations including manufacturing batch records, non-conformance reports (NCRs), Customer Occurrence Reports (COR’s), Product Occurrence Reports (POR’s), technical protocols, customer claims/complaints.• Packaging Engineer support. Evaluated, inspect, test and approve every new custom packaging.• Performed product performance testing to make sure meets drawing and customer requirements. • Clean Room expansion project management. Clean Room, utilities and equipment implementation. (Validation, quotes, project management, budget and layout.) Project Capital management.
  • Angiotech Pharmaceuticals
    Equipment Engineer
    Angiotech Pharmaceuticals Feb 2008 - Dec 2011
    • Equipment Engineer: Design, repair, troubleshoot and maintenance of all production equipment: Tumblers, Wire Straighteners, Wire Benders, Wire Cutters, Drill and Tap, Polishers, Washing/Cleaning Systems.• Improved and search for areas of opportunity, troubleshoot and modified all equipment with a goal of fast production, better quality and employee ergonomics compliance.• Injection Molding, Product Foam Cutting and Handle Print area engineering support.• Manufacturing equipment and product transfer from Syracuse, NY and Rincon, PR to merge in the new facilities at Aguadilla, PR.• 5S Methodology implementation and follow-up. Project focused on Lean Manufacturing Techniques.• Packaging, Validation and Facilities engineer support. Evaluate, prepare and document product packaging.
  • Zolidz Dezignz
    Owner
    Zolidz Dezignz Jan 2008 - Dec 2010
    • Mechanical designs and engineering services.• Custom machines and tooling design that meet the customer requirements.• 3D Printing of custom parts.• Transfer files from 2D to 3D and vice versa with CAD software.• Volkswagen Vanagon – Custom car parts.• Joseph Machine Shop – Custom parts for car, motorcycles go-karts and boats.• GE – Design of machine that attaches computer connectors to the Ribbon Cable.• Teddy’s Auto Services – Mechanical equipment repair and troubleshooting. Audio and car alarm installation. Boat maintenance, equipment installation, audio, GPS, and hardness installation. Motorcycle and Go-Kart customizer. Special requests parts designs and modifications.• G&R Innovations – Company partner on residential security alarm systems installations.• Auto-Lux Mobile Car Wash – Equipment prototype design/manufacturing and maintenance.• Client – Garden Raised Bed and Succulent Garden Frames (Wood works).
  • Pratt & Whitney
    Mechanical Design Engineer
    Pratt & Whitney Jun 2006 - Feb 2008
    East Hartford, Ct, Us
    • Aerospace services at Infotech Aerospace Services, Inc. for Pratt & Whitney.• Military aerospace mechanical design and analysis of engine components.• Design of: Externals hardware for military engines (Sheet Metal Brackets, Machined Brackets, Tubes, Harness, etc.). Valve systems for Rockets. Pipes and structural frame for Fuel Cells Power Plants.• Pro-Engineer / Unigraphics NX CAD software trainer for new employees and for employees development.• Pro-Engineer user customers project leader and drafter’s final checker and support.• Geometric Dimensioning and Tolerances (GD&T) drawing checker.
  • Hewlett Packard Enterprise
    Mechanical Engineer
    Hewlett Packard Enterprise Jan 2003 - May 2006
    Houston, Texas, Us
    • HP "TNT Logistics" equipment and building maintenance. • Pre-forming process owner: Responsible of the control of the component’s specifications for hand-loading process. Mechanical designer of custom machine tools. Components specs database, documentation, orders and shipping. Components packaging support. Team supervising, tasks and priorities assignment.• Design of manufacturing line tools, fixtures and conveyors components.• Pressfit and SMT manufacturing support.• NPI team member.• Create DFMEA and FMEA for product.• Responsible of Lean manufacturing and 5S Methodology implementation on all TNT areas.• Mechanical solutions / Tools designs and improvements to promote productivity, ergonomic and safety improvement. Ergonomics/first aid incidents, FMEA, Root Cause Analysis and failures investigations.
  • Merck Sharp & Dohme
    Predictive Maintenance Engineer
    Merck Sharp & Dohme Jun 2001 - Dec 2001
    • Predictive Maintenance Department team member.• Equipment maintenance and calibrations coordinator. Responsible spare parts and equipment database.• Equipment validations protocols and reports as well as execution support.• Knowledge in instruments and software to detect failures (Vibration analysis, Ultrasonic Thickness Test, Infrared Alignment, Dynamic Balancing, Infrared Technology, Ultrasonic, Lubrology Spectron Analysis).
  • Teddy Auto Service
    Technician
    Teddy Auto Service Jan 1999 - Dec 2000
    • Electro-Mechanical equipment repair and troubleshooting.• Audio and car alarm installation.• Mechanic assistant.• Car restoration. Specialized in detailed malfunctions repairs.• Sand Blasting and polishing for paint preparation.• Boat maintenance.• Boat equipment, audio, GPS, and hardness installation.• Use machinery equipment to fix and rebuild cars.• Auto-Part marketing, re-layout and logistics.• Web page designer.

Osvaldo Gonzalez Skills

Manufacturing Lean Manufacturing Root Cause Analysis Six Sigma Mechanical Engineering Engineering Fmea Solidworks Project Management Validation Design For Manufacturing Kaizen Injection Molding Process Engineering Microsoft Excel Quality System Gmp Unigraphics Medical Devices Powerpoint Sheet Metal Microsoft Word Equipment Maintenance Cad Aerospace Autocad Solid Modeling Machine Tools Capa Proengineer Fda Programmable Logic Electronics Supervising Me10 Teamwork Failure Mode And Effects Analysis Machinery Design Engineering Packaging Engineering Soliddesigner Rca Design Inventor Plc Programming One Piece Flow

Osvaldo Gonzalez Education Details

  • University Of Puerto Rico-Mayaguez
    University Of Puerto Rico-Mayaguez
    Mechanical Engineer
  • Colegio San Antonio - Isabela, Pr
    Colegio San Antonio - Isabela, Pr
    High School

Frequently Asked Questions about Osvaldo Gonzalez

What company does Osvaldo Gonzalez work for?

Osvaldo Gonzalez works for Johnson & Johnson

What is Osvaldo Gonzalez's role at the current company?

Osvaldo Gonzalez's current role is Head of Operations.

What is Osvaldo Gonzalez's email address?

Osvaldo Gonzalez's email address is go****@****ail.com

What schools did Osvaldo Gonzalez attend?

Osvaldo Gonzalez attended University Of Puerto Rico-Mayaguez, Colegio San Antonio - Isabela, Pr.

What are some of Osvaldo Gonzalez's interests?

Osvaldo Gonzalez has interest in Custom Motorcycles And Go Karts, Technology, Marine Navigation, Computer, Machine Designs.

What skills is Osvaldo Gonzalez known for?

Osvaldo Gonzalez has skills like Manufacturing, Lean Manufacturing, Root Cause Analysis, Six Sigma, Mechanical Engineering, Engineering, Fmea, Solidworks, Project Management, Validation, Design For Manufacturing, Kaizen.

Who are Osvaldo Gonzalez's colleagues?

Osvaldo Gonzalez's colleagues are Denise Rencevicz, Arkadiy (Arry) Zyryanov, Mahmoud Ezzat, Zill Soni, Rita Kirk, Atiki Singhal, Keith Schreiber.

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