Manufacturing Engineer II

4 weeks ago

Fort Worth, United States LanceSoft Full time

JOB DESCRIPTIONTop 3 technical skills that are required for the role:Process validation (IQ/OQ/PQ)pFMEAs, Control plansRisk assessment and evaluation.Education Required: Bachelors degree in Mechanical Engineering, Bio-Medical Engineering.Years' Experience Required: 0-5Will the contractor be working 40 hours a week? If not, weekly estimate? Yes.Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? OnsiteWhat is your timeline for scheduling interviews? In a week.What product line will this person support? CSF products.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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