Amado Gonzalez

16+ Years of experience in Medical Devices Industry. High expertise in manufacturing processes, execution and validations. Executed knowledge transfer and product transfer projects directly with California, US. Sites for 7 years. Strong Leadership skills, oriented to people development.

Biosense Webster Inc., Johnson & Johnson.
2022 - 2023
MANUFACTURING SUPERVISOR NPI
Responsible for the Nuvision (new product) introduction line, supervising failure analysis, clinical work orders request and monitoring.
Continuous communication with the Research & Development team in the Design site at California for status of the transfer project, documentation readiness and review, WO status, Failure reports and analysis and Design improvements proposals.
Basic manufacturing activities such as: line balance verification, supervision of 60+ production associates, materials tracking, packaging and shipping process and operations training and certification plan.
2020 - 2023
NEW PRODUCT INTEGRATION ENGINEER
Helios and Lassostar New Product Transfer and Validation. APQ Leader.
Validation plan and assessment.
Equipment validation, IQ, OQ, PQ, Coordination of Validation activities and supervision of NPI Engineers and technicians.
Approval of Protocols and Test Reports
Acquisition and redesign of equipment and tooling
Creation of process and validation documentation, such as: process instructions, routers, BOMs, drawings improvement.
Improvements to product design
Management of the project finances - budget
2018 - 2020
PRINCIPAL ENGINEERING TECHNICIAN
QDOT and nMarq New Products Transfer.
Support to Equipment Validation (IQ & OQ)
Purchase Orders and capital monitoring for equipment and material acquisition Calibration and Maintenance Forms
Equipment and machinery installation
Manufacturing aids
Training to Failure Analysis Technicians and operators
Kaisen Implementation.
Samples, product testing, documentation and measuring for validation activities. Strong background in training deployment for manufacturing associates. Participated in 5+ New product Transfer Projects

2021
Conversational English Tec de Monterrey
2018
Industrial Engineering Degree
Tec Milenio University
2016
Conversational English El Paso Community College