Manufacturing Engineer II

1 month ago


Fort Worth, United States Planet Pharma Full time

Manufacturing Engineer II

Forth Worth, TX

8 months

Pay: $35-43/hr


Summary:


  • Perform continuous improvements and ongoing support of existing manufacturing lines and process/product development lifecycle.
  • Navigate the complexities of government and industry regulations to include ISO13485 and cGMP (Current Good Manufacturing Practices).
  • Assist in the launching of new products and processes from concept to final release in manufacturing.
  • Utilize DOE (Design of Experiment), QSR (Quality Systems Regulations), and IQ/OQ/PQ (Installation Qualification, Operational Qualification, Performance Qualification). Understand Risk-based failure mode analysis (PFMEA and PFMECA).
  • Conduct Data Analysis using SPC (Statistical Process Control) principles and Minitab.
  • Coordinate small to medium scale projects, coordinating activities, resources, and project timelines.
  • Utilize Lean and Six Sigma practices to include DMAIC processes and root cause analysis, 5S, scrap reduction and yield improvements.
  • Coordinate various CAPA (Corrective Action /Preventative Action) projects.
  • Supporting software projects to include Microsoft Project.


Basic Qualifications:


  • Masters’ degree in Industrial, Mechanical or Biomedical
  • Engineering or related engineering field and two (2) years’ experience as a process engineer or related occupation providing process design and development; Or Bachelor’s degree in Industrial, Mechanical or Biomedical Engineering or related engineering field and five (5) years’ experience as a process engineer or related occupation providing process design and development.
  • Must possess a min. of 2 years’ experience with each of the following: ISO13485 and cGMP; Process and Product development lifecycle; DOE, QSR, and IQ/OQ/PQ; PFMEA and PFMECA; SPC principles and Minitab; Microsoft Project; Lean and Six Sigma practices to include DMAIC process, root cause analysis, 5S, scrap reduction, and yield improvements; and CAPA.

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