Juan Felipe Esquivel Paez

Cell: ***.***.**.**

E-mail: adh6df@r.postjobfree.com Birthday:06/20/1991

SUMMARY: Mechatronic Engineer with over 5 years of experience in the healthcare industry, focused on manufacturing process with highly regulated environments, performing Quality systems, process and equipment automation roles. Ability to Interact with other functional areas and corporate functions to achieve the company goals. Results oriented, teamwork player and multicultural.

EDUCATION

Mechatronics Engineering (Focused on Automation and electrical control) 2012-2017 Universidad tecnológica de Tijuana (UTT)

IT Technician

2008-2011

CETis # 156, Tijuana B.C.

EXPERIENCE:

JABIL HEALTHCARE June 2020- Actually

QA Software Validation Engineer:

-Ensure that all requirements of ISO 13485,21 CFR 11,820 related to software control and the master site validation plan are adequately met.

-Creation of Software validation protocols and reports.

-Change control final approver, Software system assessment creation.

-Develop and execute test cases scenarios to computer systems validation.

-Software systems assessment.

-Update and maintain procedures and documentation related to software validation.

JABIL HEALTHCARE March 2019- June 2020

Lead Automation Engineer: Part of an NPI team for the transfer of a new Client in a new plant, execution of the activities according to the timeline following the required standards.

-New lines introduction (FAT, IQ, OQ, PQ).

-Document creation for equipment’s introduction (DHR, PM cards, SET-UP sheet, work instructions, manuals,drawings).

-Review equipment/process requirements (automatic/manual Operation, safety, Scrap rate, cycle time, documentation etc.)

-Lean bronze certification (Kaizen projects).

-Problem solving techniques.

-Machinery spare parts analysis.

-Preventive and corrective maintenance.

-Troubleshooting.

BD Medical Systems (CareFusion) Feb 2018- March 2019

Automation and control technician. Ensure the product realization and operation of the equipment according to quality standards and productivity goals.

-Mechanical design (solidworks)

-New project introduction (technical support). Machinery validation.

-Troubleshooting.

-Execution of preventive maintenance routines according to the maintenance plan.

-Set-up, Troubleshooting, preventive and corrective maintenance in the following advanced technologies:

PLC Allen Bradley

Leak testers (Zaxis)

Variable frequency drives

Sealers (Urania).

Vision systems (Cognex).

Ultrasonic welders (Branson/

Dispensing lubrication.

Laser Markers (Keyence)

Carl Zeiss Vision June 2016 - July 2017

Maintenance/automation Technician:

-Ensure the equipment maintenance plan TPM.

-Improve KPI’s (OEE, MTTR, MTBF, Failures investigated, Rework,etc.)

-Ensure the product realization and operation of the equipment according to quality standards and productivity goals.

-Supplier coordination for improvement projects in automation, training design, trouble shutting creation, visual aids creation).

-Automation of the machine “Tapping” (bottleneck) to improve the performance and reduce the down time.

-Training and Visual Aids creation for maintenance team for SET-UP and new equipment introduction.

SKILLS:

Teamwork player and multicultural.

Knowledge in ISO 13485:2016 and FDA regulation.

Experience in transfer lines for medical industry.

FAT/SAT/CSV and IQ Validations in the medical industry.

Strong knowledge in maintenance and automation Knowledge in Lean Manufacturing techniques.

SPECIAL COURSES:

OTHERS:

- LabVIEW

-SOLIDWORKS

- Vision system training (Cognex).

- TPM (MTBF/MTTR).

- LOTO (lockout/tagout).

- PLC Allen Bradley (medium).

- PLC Siemens (basic).

- ISO 13485:2016 (Internal auditor).

-US valid Visa.

-Driver’s license in force.

-Schedule Availability.

- Availability to travel.

Contact this candidate