Summary
Overview
Work History
Education
Skills
Timeline
Generic

Jaime Martinez

Northridge,CA

Summary

Senior Manufacturing Engineer experienced working with early stages of product design and medical device development. Background includes over 10 years of experience in Equipment Validation, New Product Development, Quality Engineering and Project Management.

Overview

13
13
years of professional experience

Work History

Senior Manufacturing Engineer

Medtronic
01.2023 - Current
  • Developed, reviewed, and wrote documents for Process Validation (IQ, OQ, PQ), Master Validation Plans, Test Method Validation, Inspection Method Validation (IVM), Process FMECAs.
  • Wrote and implemented inspection procedures, trained inspectors in use and maintenance of equipment and tools, while aiding in the equipment selection and upgrading process.
  • Released product upgrades for annual revenue by generating Engineer Change Orders (ECO) for Bills of Materials (BOM) and Manufacturing Assembly Process and Documentation. Also developed Quality Transfer Plans by consolidating and reviewing routers, bill of materials (BOM), production set up sheets, Standard operating procedures (SOP) and technical protocols.
  • Lead multi-functional new project teams in developing risk assessments, design inputs, test and inspection procedures and specifications and design review meetings. Conducted Trend Analysis for complaints, CAPA and SCARs in ETQ.
  • Involved in continuous improvement tools, such as FMEA, Root Cause Analysis, SPC analysis, PPAP, APQP and process mapping. Performed validations (IQ/OQ/PQ) of manufacturing related processes and equipment.
  • Developed Engineering Change Orders for process improvements, new equipment introductions, and regulatory compliance. Drive device and manufacturing history records for non-conformity and changes in the manufacturing process.
  • Created and updated Procedures and work instructions to comply with ISO-13485:2016 standards and FDA Current Good Manufacturing Practices (cGMP) for Medical Devices. Authored, reviewed, and executed DFMEA, PFMEA, Quality Plans (QP), Master Validation Plans (MVP), Validation Protocols, IQ, OQ, PQ, Summary Reports, Standard Operating Procedures (SOP) and Work Instructions (WI).
  • Assisted design engineers in conducting Design for Manufacturing (DFM) studies for New Product Introductions (NPI) and New Product Development (NPD) projects.
  • Ensured all issues/documentation associated with each process in assigned area have been resolved prior to release to the next step and are compliant with cGMPs and SOPs and current manufacturing regulations and site procedures.
  • Collaborated with Contract Manufacturer and Original Equipment Manufacturers (CM/OEM) teams to check for the specifications of received components and materials as per requirements.
  • Work with suppliers, manufacturing, engineering, and other functional areas to assist and verify timely implementation of corrective actions taken for complaint and remedial action issues.
  • Communication of quality issues to suppliers as needed through supplier quality system audits, supplier corrective action requests and technical discussions.

Principal Manufacturing Engineer

Motherson Sumi Systems
01.2020 - 12.2022
  • Implemented global quality system initiatives for continuous improvement of product design, lean manufacturing and supplier quality that enhanced product quality, reduced cost, increased yields and operational efficiency using empirical tools such as: DMAIC, DFM, Risk Analysis, Root Cause Failure Analysis, Design Requirements, DFMEA's, PFMEA's, TMV's, Statistical Analysis and others.
  • Identified problems and specific resolutions to fix defective, damaged or malfunctioning parts, assemblies, equipment and systems.
  • Reviewed legacy supporting documentation: TMVs, SOPs, MVPs, PSWs, FMEAs, DFMEAs, DVs, DVP, DOEs, Control Plans, and BOMs.
  • Selected manufacturing methods, fabrication and operations to develop and coordinate production.
  • Reviewed, dispositioned, and resolved In-process Production quarantines, Receiving Inspection non-conformances, and external complaint issues. Created, updated, and implement manufacturing documentation including engineering drawings, bill of materials (BOMs), and verification and validation protocols and reports to ensure accurate documentation and quality of product in a ISO13485 manufacturing environment.
  • Optimize designs for production using DFA /DFM principles.
  • Supported manufacturing process development & qualification for new product commercialization and product changes.
  • Developed Test Methods and Test method validation protocols (TMV) for plastic molding machines and emergency medical equipment.
  • Prepared and negotiate Quality Agreements with Direct Suppliers Like- Contract Manufacturing, Components, Packaging, Metals, Electronics, and Indirect Supplier - Supplies, Consumables, Capital Equipment and Services, Lab, and Calibration.
  • Performed failure investigations, determined root cause of failures for internal and external complaints, determined corrective actions to be taken and wrote complaint reports, while determining correct resolutions for assigned corrective actions.
  • Generated Non-conformances and CAPAs (Corrective and Preventive Actions), investigated corresponding events, reviewed, and completed documentation.
  • Supported audits/site inspections and provided responses to applicable inquiries pertaining to job responsibilities.
  • Evaluated complaints to determine whether an investigation was necessary and if Medical Device Reporting (MDR) was necessary in accordance with 21 CFR Part 803 Medical Device Reporting and 806 Corrections and Removals, Canadian regulations, European Vigilance Reporting, and any other worldwide regulatory requirements.

New Product Development Engineer

Zf Trw
09.2016 - 12.2019
  • Planned introduction of new programs following APQP methodologies and responsible for meetings with all departments involved to ensure a lean production.
  • Facilitate planning, organization, development, and integration of the Engineering team.
  • Tracking and follow-up on all projects for on time completion of tollgates and specified deliverables.
    Coordination and management with suppliers for excellent design and execution of the deliverable.
  • Requested project prospects for the acquisition of resources, capital budgets, expenses, capital requisitions and engineering orders.
  • Coordinated validation, transfer, development of equipment corresponding to supplier manufacturing plant.
  • Ensured the closure of all actions according to the audit process.
  • Helped to define the project scopes in collaboration with senior management and regional team.
  • Created a detailed work plan which identifies and sequences the activities needed to successfully complete the project.
  • Ensured that the project deliverables are on time, within budget and at the required level of quality.
  • Meetings with vendors, staff, and management personnel regarding purchases, procedures, product specifications, manufacturing capabilities and project status.

Process Engineer

Takata
05.2011 - 09.2016
  • Provided technical assistance to production team when issues arose.
  • Reviewed processes, identifying areas requiring improvement.
  • Conducted root cause analysis to identify, prioritize and eliminate process losses.
  • Participated in project reviews to enable ongoing status tracking and reporting.
  • Prepared scope of work documentation for use in project planning
  • Developed documentation, diagrams, and specifications to meet project requirements and regulatory standards.
  • Coached newly hired employees and interns while observing progress and delegating tasks.
  • Met weekly with team members to discuss project implementations and alleviate any issues.
  • Managed third-party contractors, inspecting completed work and ongoing efforts to confirm quality and adherence to prescribed guidelines.
  • Analyzed critical line data to make recommendations for improvement.
  • Interfaced with area teams to verify application of technical details.
  • Collaborated with technologists to address operating issues and support rapid recovery.
  • Developed conceptual scope analyses of project objectives.
  • Documented feasibility and implementation of third-party projects for review and future reference.
  • Visited client sites to troubleshoot issues and provide one-on-one training.
  • Evaluated proposed project economics and identified alternative solutions and designs producing improved results.
  • Reduced downtime and increased production capacity with strong maintenance plans.
  • Led root cause analyses to identify and address problems in industrial production.

Education

Bachelor of Science - Industrial Engineering

NATIONAL TECHNOLOGICAL INSTITUTE OF MEXICO
MEXICO
05.2011

Skills

  • Equipment Validation Expert
  • Advanced Process Engineering
  • Project Management
  • Cost Reduction and Efficiency
  • Quality Management Systems
  • Change Management
  • Continuous Improvement Strategies

Timeline

Senior Manufacturing Engineer

Medtronic
01.2023 - Current

Principal Manufacturing Engineer

Motherson Sumi Systems
01.2020 - 12.2022

New Product Development Engineer

Zf Trw
09.2016 - 12.2019

Process Engineer

Takata
05.2011 - 09.2016

Bachelor of Science - Industrial Engineering

NATIONAL TECHNOLOGICAL INSTITUTE OF MEXICO

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Jaime Martinez