Jennifer Louie-Monzon
Medical Device Engineering Consultant @Irwin & Associates, Inc
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WORK HISTORY
Medical Device Engineering Consultant @Irwin & Associates, Inc
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
ABOUT JENNIFER LOUIE-MONZON
Engineering Consultant at Irwin & Associates, Inc.
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