Jennifer Louie-Monzon

Medical Device Engineering Consultant @Irwin & Associates, Inc

San Francisco, CA, US
MOBILE NUMBERS
+16•••••••38

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WORK HISTORY

Mar 2010 — Present

Medical Device Engineering Consultant @Irwin & Associates, Inc

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San Francisco, CA, US

Current and past clients include: Verily Life Sciences/Google Life Sciences/Google X, Stryker Neurovascular, Avinger, HeartFlow, Conmed/Linvatec, Sadra Medical, Boston Scientific: Cardiac Rhythm Management divisionProvide medical device clients with manufacturing & quality engineering and technical writing support- Manufacturing assistance includes creating and releasing all documents required for V&V and production builds, training assemblers, simple tool & fixture design, and vendor collaboration- Quality Engineering includes project support, setting up and maintaining a simple document control system, and audit team member- Documentation includes, but is not limited to, MPI/WI, device master record (DMR), inspection instructions, design V&V, IQ/OQ/PQ, instructions for use (IFU), service manuals, and material specifications.

SKILLS

R&DBiomedical EngineeringDesign of ExperimentsManufacturingDmaicManufacturing EngineeringSix SigmaSpcChange ControlQuality ControlGmpInjection MoldingDesign for ManufacturingQuality AssuranceIso 13485Surgical InstrumentsTechnical DocumentationSoftware DocumentationRoot Cause AnalysisProcess DevelopmentTechnical WritingIsoFdaProcess EngineeringProduct DevelopmentDesign ControlLean ManufacturingSustaining EngineeringValidationFailure Mode and Effects Analysis (Fmea)Process ImprovementCross-Functional Team LeadershipIso 14971Fmea21 Cfr Part 11Quality SystemV&VEngineeringDocument ManagementProcess Simulation

ABOUT JENNIFER LOUIE-MONZON

Engineering Consultant at Irwin & Associates, Inc.

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