Ariel Gaytán

Mechatronics Engineer with 5+ years of experience in medical device and automotive industries. Skilled in process validation (IQ/OQ/PQ), equipment qualification (FAT, SAT, TMV), and driving process optimization to improve efficiency and reduce costs. Strong track record in continuous improvement projects and ensuring compliance with GMP, ISO 13485, and FDA regulations.

Design Engineer - JOHNSON & JOHNSON (Biosense Webster) - Juarez, Chihuahua

(2021-04)

• Develop, detail, and implement process and equipment solutions to improve safety, quality, delivery, and cost efficiency on existing production lines. Additionally, design and acquire manufacturing tools and equipment to optimize productivity, maintainability, and cost.
• Creation of detailed technical drawings and management of approval workflows through Windchill PLM system, ensuring accuracy, compliance with design standards, and timely release for manufacturing. Collaborate with cross-functional teams (Engineering, Quality, Production) to maintain uninterrupted operations.
• Created reports and dashboards focused on digital quality solutions, applying digitalization principles and logical analysis.
• Participated in continuous improvement activities, CAPA investigations, internal audits, and training programs, ensuring compliance with critical deadlines.
• Developed protocols and reports for process and product validation, equipment qualification, and engineering change management.(IQ, OQ, PQ, FAT, SAT, TMV).

2D CAD Designer - APTIV - Juarez, Chihuahua

(2018-01 - 2021-04)

• Handled engineering change request and BOM updates, helping reduce production cost.
• Created 2D and 3D drawings, wiring diagrams, and technical schematics to support faster and easier manufacturing (Autocad).
• Worked as a link between suppliers and engineering teams, improving product quality and speeding up delivery times.

Mechanical Designer - Harness and Solutions (FIDSA) - Juarez Chihuahua

(2017-01 - 2018-01)

• Designed mechanical components with SolidWorks, ensuring GD&T standards were applied.
• Developed manufacturing drawings and coordinated with production teams for feasibility and optimization.

Mechatronics Engineering - Mechatronics - Universidad Autónoma de Ciudad Juárez (2023-05)