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