Experience

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  Chimaps bilingual school

  Jan 2014 - Jun 2014

  Math teacher

  - Math Class per Academy’s Handbook to 7th, 8th, 9th, 10th, 11th, and 12th graders.- College Board Preparation- Math Class

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  Viant medical

  Jun 2014 - Mar 2023

  Manufacturing Combination Product (Engineering of new Combination Product Development)-Worked hand-by-hand with R&D team; reporting of results, resolution of components and assembly performance, dimensional, and defects issues, through troubleshooting, root cause investigation, and implementation of corrective and preventive actions for the new manufacturing lines, to ensure assembly’s performance and conformance of individual components.-Summarizes, analyzes, and draws conclusions and recommendations from complex test results to R&D, Assembly, and Molding Teams.-Project Management, Validation reports, execution, closure, Technical Analysis, and communication of results and recommendations of appropriate revisions to R&D cross-site teams.-Lead Injection Molding area (qualifications of new tools, processes, and development of internal manufacturing and quality documentation).-Support Assembly area (troubleshooting of equipment and product assembly process, performance, etc.).-Support Purchased Components assessment, qualifications, etc.-Ensures that new product introduced to the production floor meets business, quality, output and cost goals and objectives.-Selects process improvements techniques to solve technical problem and makes sound equipment and process recommendations. Has a broad knowledge of a variety of alternatives and their impact on the business unit.-Collaborate with cross-functional and cross-site teams.-Support on Capital Equipment Request Authorizations (CERA’s).-Acquisition of Equipment; placed PO’s, monitor ETA, coordinate arrival, coordinate calibrations, certifications, validations as needed, ensure readiness of equipment for tools and process qualification.-Supports on Cost Analysis of purchased product, manufactured product, and Final Product, against quoted prices on RFQ/CPE.-Provide guidance, offer counsel, and train Junior Engineering Staff. Show less Manufacturing-Trains and/or provides work direction to operators/technicians.-Perform “Gemba” walks to audit machine and operator related processes to evaluate performance, issues, and areas of opportunities-ERP system; Creation of components, manufactured product, work centers, locations, tools, BOMs-Collaboration with Tool Fabricators to submit input and recommendations on Tool Design (DFM), EOAT Design, Inspection Fixtures Design & Inspection MethodProject Management-Lead and support projects---Lead qualification activities for injection molding area---Support qualifications for Sub-Assembly, Assembly, and Packaging areas-Lead corporate projects within site; Transfer of Tools from another fellow facility on closure, Implementation of new ERP System (IQMS)-Collaborate on product development with R&D at US facilities-Maintain communication with cross-sites teams, customers, vendors, and cross-functional areasValidation Engineering-Writing/Review/Approval; Protocols, Reports, Engineering Summary, Technical Reports-Process Validation; MVP, MVR, IQ, DOE, OQ, PQ, TMV-Equipment Validation; IQ, DOE, OQ, Inspection Fixtures-EHS- Hygiene Qualification (for Drug API exposure)-Test Method Validation; Gage R&R, Gage Type-II, AAA, Correlation Study, Instrument Selection & Measuring Techniques, Vision System (VMA, OGP), GD&T-Statistical Methods and Analysis; Process Capability Analysis (Cpk), Tolerance Interval Analysis, Normality Test, T-Test, Scientific Injection Molding (SIM) Approach, Process Sensitivity Analysis on CTQ’s, Shrinkage Study (Injection Molding), Process Control Study, Failure Analysis (defects, and re-occurrences)EHS-Worked on three (3) Cleanrooms Hygiene Validations-Purchase Orders, for acquisition of safety equipment and Coordination of Waste management -Implementation of security measures-Revision of procedures for new EHS practices of new product-EHS Assessments for new equipment-Ergonomic Assessments for the new Workstations Show less Quality Assurance /Customer Accounts-Root Cause Investigation Analysis for non-conformances; Complaints, SCAR’s, NC’s, CAPA’s-Development, review and revisions of internal documents; Procedures, Forms, Work Instructions (MPI), Quality Inspections, Process Sheets, PFMEA, Process Flow Diagrams, BOM, Qualification Protocols & Reports-Customer Service/Customer relationship-Drumbeats with variety of customers-Supplier Change Notifications-Material Review Board (MRB) participation-Review and Approve Batch Documentation (LHR)-Personnel Training on procedure and documents revisions, complaint awareness, etc. for cross-functional areas-Injection Molding Process Re-Validations for; Tool Repairs, Process Changes, Material Changes, Equipment Changes for multiple customers-Injection Molding Validations for New Tools from New Customers-Upload and review of documentation on Quality System (Master Control)-Support Manufacturing floor and Operations-Implements techniques to reduce inspection cost, such as improved inspection methods and aids, automated test equipment, and efficient application of sampling techniques-Perform “Gemba” walks to audit machine and operator related processes to evaluate performance, issues, and areas of opportunities as applicableCompliance-CAPA’s, Deviations, Non-Conformance Events-Review and Revision of SOP’s to align to current practices-Support Audits (War Room; reviewer, allocation of documents, others); BSI, Internal, Customers, FDA-Audit Observation Responses (Root Cause Investigation, Implementation of actions, and closure)-Injection Molding Clean Room & Sub-Assembly BSI Class 8 Cleanroom Certification & Validation; Project Management & ExecutionSupplier Quality Engineering-Assess & Evaluate Suppliers for new product development purchased components-Component Qualification for new products-Communication of results & recommendations to R&D divisions (cross-sites) for new product development to align component specifications Show less

  • Senior Manufacturing Engineer

    Jul 2022 - Mar 2023

  • Manufacturing Engineer

    Aug 2018 - Jul 2022

  • Quality Assurance Engineer

    Jun 2014 - Aug 2018
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  Boston scientific

  Nov 2023 - now

  Neuromodulation Leads Neuromodulation Leads-3 Piece Tubing Fusion Project-Process Development, Characterization, and Qualification.-Equipment Commissioning; Asset Inclusion, Generation of Maintenance & Calibration Procedures.-Tools & Equipment Qualifications; Protocols, Execution, IM&T, Report.-Document Control Systems; Windchill, DOCS, GlobalWorkflow.-Asset Control System; Blue Mountain (BMRAM)

  • Senior Manufacturing Engineer

    Oct 2024 - now

  • Validation Specialist

    Nov 2023 - Oct 2024