Brooke McGinley

Engineering Manager

Role
Senior Manufacturing Engineering Manager at Microline Surgical
Location
Boston, MA, US
LinkedIn followers
500 followers

About Brooke McGinley

Engineering Manager with a strong working knowledge of the Design and Manufacturing of Class I, II, and Medical Devices, with a focus on In Vitro Diagnostic Regulation (IVDR) and Medical Device Regulation (MDR) per 21 CFR 820 FDA, QSR, ISO 10993, 13485, and ISO 14971 principles from design through FDA Approval and into full-scale Manufacturing within an US FED STD 209E / ISO 7 Class Cleanroom

Experience

  1. Senior Manufacturing Engineering Manager

    Microline Surgical

    Jul 2024 — Present

Education

  • University of Massachusetts at Lowell

    Master's of Science, Mechanical Engineering

  • University of Massachusetts Lowell

    Bachelor's degree, Mechanical Engineering

  • Mystic Valley Regional Charter School

    High School, International Baccalaureate, National Honors Society

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Brooke McGinley — Senior Manufacturing Engineering Manager at Microline Surgical in Boston, MA, US | Unifers