JOSE RIVAS
Quality Engineer I
Tijuana,Baja California
Summary
My goal is to apply my skills and knowledge in a dynamic environment where I can contribute to the development of innovative products and improve the efficiency of manufacturing processes. I am looking for an opportunity that will allow me to grow professionally and continue learning in a collaborative and results-oriented environment.
Overview
3
3
years of professional experience
6
6
years of post-secondary education
1
1
Language
Work History
Quality Engineer I
Medtronic
Tijuana, Baja California
07.2024 - Current
- End to end support to end item Catheters manufacturing Lines used resolving quality issues in a fast and efficient way
- Track the daily Quality RTY of manufacturing lines and reporting results to the PST
- Multiple equipment qualification for quality tests as a Water Bath to perform Leak and Burst Tests and a Pull tester Machine used for all the products of the Clean Room (EDQ, IQ, OQ, TMV)
- Conduct DHR reviews resulting from low-level field material complaints
- Conduct CAPAs and NCMRs from internal non conforming material
- Track and perform multiple corrective and preventive actions resulting from con conforming material issues
Manufacturing Engineer I
Medtronic
Tijuana, Baja California
12.2023 - 05.2024
- Worked in the Extra capacity project transferring end item 3 manufacturing lines conducting multiple validations.
- End to end support to end item Guide Catheters manufacturing Lines
- Qualification for multiple equipment’s
- Conduct DHR reviews resulting from low-level field material complaints
- Lead the UKCA Integration Project to create new FGs complying with the regulations and standards of the new UKCA standards into over 1000+ guide catheter models, covering 4 product families, in close collaboration with MEDTRONIC Ireland
NPI Manufacturing Engineering Support III
Jabil Healthcare
Tijuana, Baja California
04.2022 - 10.2023
- Worked in a product transfer from San Jose CA to Tijuana B.C
- Collaborated with customer to create work instructions
- Responsible for transferring, translating, and aligning various documentation sent by the customer to Jabil quality system
- Created and executed Engineering Change Notice, Change Requests and ECOs
- Procured materials required for the manufacturing line (MRO, Tools, Miscellaneous, Chemicals, Fixtures, Equipment, etc.)
- Creation of Installation Qualification protocols (IQP) and reports (IQR) for multiple equipment
- Creation of Operational Qualification Protocols (OQP) for multiple Pouch Sealer Equipments
- Conduct and execute Performance Qualification Protocol (PQP) for the release of product mass production
- Conducted Engineering Study's required for the Design validation verification process and Bioburden / Sterility audits
- Worked directly with customers for protocol creation (IQ, OQ, PQ, ES)
- Worked in multiple RCAs in collaboration with customers using Ishikawa, 5Whys
- Documented incidents and tracked them to ensure the correct closure (Deviations)
- Worked in the creation of Bill of Materials (BOM) for multiple Finished Goods
- Creation of Process a Failure Mode Effects Analysis (PFMEA) for a new product
- Creation of Device Master Record (DMR) for a new product.
NPI ME Talent Bench (Intern)
Jabil Healthcare
Tijuana, Baja California
10.2021 - 04.2022
- Worked in a transfer from Milpitas CA to Tijuana B.C
- Collaborated with customers to create work instructions
- Responsible for transferring, translating, and aligning various documentation sent by the customer to Jabil quality system
- Created and executed Engineering Change Notice and Change Requests
- Procured materials required for the manufacturing line (MRO, Tools, Miscellaneous, Chemicals, Fixtures, etc.)
- Trip to customer's plant (Milpitas C.A.) for the assessment of transferring lines.
Education
Bachelor of Science - Electromechanical Engineering
Instituto Tecnologico De Tijuana
Tijuana B.C 01.2017 - 06.2023
Skills
- Proficient in MsOffice (excel, power point, word, visio)
- AGILE, WINDCHILL, SAP
- Experienced in Lean Six Sigma projects and Root Cause Analysis (A3, 8D, 5S, Standard Work, Problem Solving)
- Knowledgeable in the NPI process and industry Medical ISO-13485 validation IQ, OQ, PQ and transferring new models from customer’s site
- Skilled in working in regulated environments like ISO/FDA, ISO13485, GMP's and GDP’S
- Experienced in controlled rooms such as Level 8 Clean Room and High Level Assembly areas (CEA, HLA, ESD control)
- Committed
- Team collaboration
- Proactive
- Communication skills
- Interpersonal skills
- Attention to detail
- Strong customer service and customer focus
Timeline
Quality Engineer I
Medtronic
07.2024 - Current
Manufacturing Engineer I
Medtronic
12.2023 - 05.2024
NPI Manufacturing Engineering Support III
Jabil Healthcare
04.2022 - 10.2023
NPI ME Talent Bench (Intern)
Jabil Healthcare
10.2021 - 04.2022
Bachelor of Science - Electromechanical Engineering
Instituto Tecnologico De Tijuana
01.2017 - 06.2023
Similar Profiles
Anna Marie ErvinAnna Marie Ervin
Sales Solutions Coordinator - Diabetes at MedtronicSales Solutions Coordinator - Diabetes at Medtronic
Emery T. DossEmery T. Doss
Mechanical Product Engineering Intern at MedtronicMechanical Product Engineering Intern at Medtronic
CHASE MARSALIS BLACKWELLCHASE MARSALIS BLACKWELL
Sale Representative II at MedtronicSale Representative II at Medtronic
Karianne KirkKarianne Kirk
Senior Principal Clinical Specialist at MedtronicSenior Principal Clinical Specialist at Medtronic
Vanessa Gonzalez NuñezVanessa Gonzalez Nuñez
Junior Quality Engineer at IMIJunior Quality Engineer at IMI