Osvaldo Gonzalez Email & Phone Number

United States

New Brunswick, NJ, US

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.

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.
• 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.
• 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.

• 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..
• 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).

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.
• 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.
• 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.
• Accountable for the direct supervision of engineers and/or engineering technicians during the product transfer. Accountable for projects cost and financial analysis.

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.

• 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.

• 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.

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.

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.
• Design of manufacturing line tools, fixtures and conveyors components.
• Pressfit and SMT manufacturing support.
• NPI team member.
• Create DFMEA and FMEA for product.

• 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).

• 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.

Bachelor'S Degree, Mechanical Engineer

High School, High School