Kerry McMullen

Principal Manufacturing Engineer

Role
Sr Operations Program Manager at Valeritas
Location
Plymouth County, MA, US
LinkedIn followers
500 followers

About Kerry McMullen

Principal New Product Engineer experienced in invasive and non-invasive medical…

Experience

  1. Sr Operations Program Manager

    Valeritas

    Oct 2018 — Present · Marlboro, MA, US

    Sr. Program Manager responsible for the support of four manufacturing production lines at various CMO\'s in China. Manage a team of four automation engineers in the design, support and upgrades of the manufacturing lines to meet monthly demands of 400K insulin device assemblies per month. Work daily with the CMO\'s to ensure IO/OQ,PQ, PPQ, FAT, and SAT documentation is completed on time. Ensure CMO maintains VMP\'s and follows cGMP. Implement new capital equipment projects exceeding $750K per year. Projects include automated X-Ray inspection, full automation assembly, and vision systems.

Skills

  • Iq, Oq, and Pq
  • Welding
  • Dfm/a
  • Procedures Manuals
  • Electronics Manufacturing
  • Smt
  • Injection Molding
  • Solvent Bonding
  • Adhesive Bonding
  • Range Studies
  • Bom Structuring
  • Mrp / Erp
  • Mrp
  • Validation
  • Design for Manufacturing
  • Dfmea
  • Product Development
  • Spc
  • Manufacturing
  • Product Design
  • Engineering
  • Medical Devices
  • Iso 13485
  • Policy
  • Cad
  • Design of Experiments
  • Testing
  • Quality Assurance
  • Fda
  • Fmea
  • Quality System
  • Iso 14971
  • Capa
  • Gd&T
  • V&V
  • Root Cause Analysis
  • Minitab
  • Dmaic
  • Solidworks
  • Iso

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Kerry McMullen — Sr Operations Program Manager at Valeritas in Plymouth County, MA, US | Unifers