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Manufacturing Engineer Contingent Resume

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Fort Worth, TX

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SUMMARY

  • A Mechanical engineering professional, with thorough experience in standard quality testing of medical devices for various applications, intends to work as a medical device quality/manufacturing engineer for a leading organization
  • Excellent understanding of FDA Quality System Requirements, TMV, BOM, quality auditing, MDR and CAD drafting
  • Patient focused individual with risk management, excellent communication, problem solving, troubleshooting skills
  • Sound knowledge of Gauge R&R, pdFMEA, Product testing methods, GD&T, machine tools validation and blueprints reading
  • ISO 14644 class 10 cleanroom experience and well versed with medical device risk assessment procedure

TECHNICAL SKILLS

CAD Designing & Analysis: AutoCAD, SOLIDWORKS, Siemens NX, CREO, COMSOL Multiphysics

Other Applications: Microsoft office, Minitab, Team center, ERP SAP R/3, ENOVIA, Mapics XA

Programming: CNC, CMM, OPTIV

Metrology tools: Surface profilers, Gauges, Optical Comparator, Vision X (Mylar)

PROFESSIONAL EXPERIENCE

Manufacturing Engineer contingent

Confidential, Fort Worth, TX

Responsibilities:

  • Executed IQ, OQ, PQ validation for sealers, CNC grinders, Brazing and welding machine for surgical tools manufacturing
  • Qualified Fixture, tooling and jigs for manufacturing of Neurosurgery disposable tools manufacturing
  • Updated work instruction, process routers, IQ protocol and created ECR, DCR for engineering change in Agile CMS
  • Dispositioned NCMRs, SCARs and used RCA, 5Why’s technique to determine process non - conformance
  • Designed custom tooling, Jigs and fixtures on CREO for manufacturing & updated CAD model on PLM Windchill
  • Created pdFMEA, MPRA for grinding process. Created Laser program for marking Lot no & GTIN number on product
  • Executed Gauge calibration, Gauge R&R on CTQ features and developed OPTIV-CMM program for inspection of parts
  • Created FCA, FCP and MC's for components, addressed rationale for critical features and updated them in CMS as requestor
  • Carried out First Article inspection, TMQ for gauges and calibration non-conformance assessment as per criteria for CAPA
  • Processed & evaluated NCR for non-conforming parts in ENOVIA and preventive actions to reduce manufacturing defects
  • Developed IQ, OQ & PQ validation protocols of CNC machine tool for orthopedic medical device manufacturing
  • Designed, fabricated & calibrated MEMS heat sensors and checked their repeatability & reproducibility as per MSA
  • Developed work instructions, SOP’s for measurements, calibration and MEMS fabrication in a cleanroom
  • Evaluated material and product testing to assist R&D initiatives of advanced material characterization using DOE
  • Executed testing of final product, identified nature of defect using RCA, FMEA & corrective actions to minimize defect
  • Assured quality of products by statistical control tools Cp, Cpk using Minitab; Reviewed PFMEA and control plans for gaps
  • Worked with cross-functional team for corrective action efforts and countermeasure actions using 8D and 5-why
  • Experienced with change management system for revised parts in Teamcenter and SKU’s rationalization
  • Standardized workflow of molding value stream by implementing Kaizen, 5S quality continuous process improvement tools.

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