Irvin A. Rivera Ibarra
Ciudad Juárez, Chihuahua,CHH
Summary
Accomplished Process Engineer with more than 10 years enforcing compliance and process improving steps in accomplishing Business Unit goals. Resourceful professional eager to utilize analytical and problem-solving skills. Willingness to take on added responsibilities to meet team goals. Meticulously investigates and tracks defects' root causes. Dogged eliminator of faults and liabilities resulting in negative financial impacts. Driven Quality Assurance professional offering dynamic understanding of manual and automated testing strategies. Highly communicative and experienced in data analysis. Focused with experience in medical manufacturing validation. Insightful individual when testing systems to observe, analyze, measure, and calibrate processes and equipment to drive accuracy and quality. Thorough understanding of QSR and ISO regulatory requirements. Experienced with background writing manual test cases and automated test scripts. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Staff Process Engineer
J&J MedTech/Ethicon
10.2016 - Current
- Evaluated the implementation of new technologies and equipment upgrades to enhance overall process capabilities, ensuring market competitiveness and quality standards. To mention some implemented technologies: the MCS (Medical Cleaning Station), and the Case Sealer Smart System at the packaging operations.
- Collaborated with cross-functional teams to identify opportunities for process improvements which result for achieving the OEE% goals for the Bussiness Unit and a higher product quality mitigating the low scrap cost losses at the packaging area.
- Participated in internal and external audits, such as TUV, to ensure compliance with industry standards and regulations relating to product quality resulting in successful closure within stipulated timelines.
- Conducted root cause analysis on recurring non-conformance defects, leading to targeted solutions and long-term improvement in product quality through the J&J Quality Systems.
- Supported the implementation of new technologies as CAPA corrective actions for better detection of defects and improved overall product inspection capabilities to mitigate Customer Complaints occurrences for mixed and missing components prevention and detection into the package.
- Support the Monarca Packaging Operations Recovery Plan which was successfully accomplished, resulting that $15MM Back Order by April 30 for Endocutter family – AMP and Wylie, was reduced to $1.5MM at Q2 closing. Same trend continued an by end of August BO was less than $.75MM. A cross functional collaboration was key for the success of this plan. An extended team of Manufacturing, operations technicians, process Engineering and Planning. Outstanding coordination of rhythm wheel on production volume, proactive maintenance execution, as well proper equipment troubleshooting and escalation process flow to ensure this result.
- · Participate in the Alcatraz Damaged Boxes Reduction Workshop at EES Independencia. The team included quality and operations from Memphis Logistics center, EES SQ, MQSA, Customer Experience Engineering, Package Development, External Manufacturing, in close collaboration with team members from quality and engineering.
- ·Lead the qualification and implementation of the CxE Cleaning Cart equipment is cleaning 100% of Powered Endocutter Devices and current performance is indicative of >2X reduction in rejected devices in Japan (In 2022, 37,728 Powered Endocutters were rejected in Japan 25.8% of overall volume | Cleaning Cart performance on
- · Act as SME for the Energy packaging operations and provide FIA input for all the Franchise Change Request Projects related to LCE, Savings, Regulatory and Compliance.
- · Lead and present the Weekly Scrap Metric Report of the Energy BU and Tier4.
- · Support the Packaging Back-Log Recovery Plan of the Q4, 2023 which was successfully accomplished, reaching out the 52K demand planning volume per week by the first quarter 2024 at packaging operations and obtaining the “Super Team” award. A cross functional collaboration was key for the success of this plan by the support of the extended team, manufacturing, operation technicians, reliability, engineering and planning. Outstanding coordination of rhythm wheel on production volume, proactive preventive maintenances, as well proper equipment troubleshooting escalation process flow to ensure this result.
- Knowledge and management of internal EES Quality Systems (AQR, ETQ MDD Nonconformances, CAPA, Audit Observation) for product impact bounding, root cause investigation, product disposition and corrective actions implementation.
- Knowledge of device risk analysis and management forms and procedures such as the CP0212 to continually drive product quality improvements that result in successful clinical patient outcomes.
- Knowledge and management of procedure for controlling design integrity of released products such as the CP0150 for planning, implementing and deploying product changes made after the design has been released into production.
- Knowledge and management of the requirements and instructions regarding the completion of Equipment Qualification, Process Validation and Process Verification, such as the ones described in the Franchise procedure PR-0000089: Validation Master Plan, TMV (GR&R), Software Validation, DOE, IQ, OQ, PQ, Engineering Studies and process verification to meet with the regulatory compliance and other requirements.
- Knowledge and management of manufacturing and risk management documentation or specification for defect qualification for the packaging area such as: Material Specification, I-Sheets, Control Plan, PFMEA, Training Manuals, Process Specification, Set up Sheet, Drawings, Visual Aids.
BEPC Consultor
Cordis De México
09.2015 - 10.2016
- Provide Validation Strategies for the Cordis de Mexico relocation site Project due the transition from Cordis de Mexico (J&J) to Cardinal Health.
- Establish high-level, Cordis de Mexico transfer site requirements.
- Perform OQ assessments for each process and line that will be involved to the transition from Cordis de Mexico (J&J) to Cardinal Health in order to mitigate the transfer risk.
- Write Process Validation Review Reports in order to document discrepancies found for any process or operation and that requires re-validation.
- Create, modify or update Part Plants, Work center, Part routings, Drawing Specs on ADAPTIV System.
- Write and execute validation protocols as part of the validation strategy defined for each production line that will be transferred from Cordis de Mexico (J&J) to Cardinal Health.
Education
Bachelor of Science - Mechatronics Engineering
Universidad Autónima De Ciudad Juárez
Ciudad Juárez, Chihuahua, Mexico11.2011
Skills
- Process Development
- Cross-Functional Teamwork
- Process Validation
- Waste Reduction
- Project Management
- Continuous Improvement
- Process Mapping
- Root Cause Analysis
- Six Sigma Methodologies
- Automation Technologies
- Quality Control Procedures
- Cycle Time Optimization
- Statistical Analysis
- Leadership Development
Certification
Six Sigma Green Belt Certification
Timeline
Staff Process Engineer
J&J MedTech/Ethicon
10.2016 - Current
BEPC Consultor
Cordis De México
09.2015 - 10.2016
Bachelor of Science - Mechatronics Engineering
Universidad Autónima De Ciudad Juárez
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