Position Description:

Engineering Program Manager for Covidien, LP (a Medtronic company) located in Irvine, CA. Lead program of responsibility, managing program performance, communicating project and operational developments. Provide input to establishing program objectives, timelines, milestones, and budgets. Guide the conceptualization of new methodologies, materials, machines, processes, or products. Directs the development of new concepts from initial design to market release and post-market (Product Lifecycle Development). Review product development requirements for compatibility with processing methods to determine costs and schedules. Perform detailed information gathering, analysis and investigation to understand and solve complex problems, utilizing data analysis software such as Microsoft Excel, Microsoft Project, and Minitab.Utilize Product Lifecyle Management (PLM) tools such as Agile, SAP, and QAD. Navigate the complexities of government and industry regulations to include ISO 9001, ISO13485, ISO 14971 and cGMP (Current Good Manufacturing Practices). Utilize DOE (Design of Experiment), SPC (Statistical Process Control), QSR (Quality Systems Regulations), IQ/OQ/PQ (Installation Qualification, Operational Qualification, Performance Qualification). Understand Risk-based failure mode analysis Process Failure Mode Effects and Analysis and Process Failure Mode Effects Criticality Analysis (PFMEA and PFMECA). Understand Process characterization, Process Qualification, and Validation Protocols. Utilize Lean and Six Sigma practices to include DMAIC processes and root cause analysis, 5S, scrap reduction and yield improvements.

Basic Qualifications:

Requires a Master’s degree in Mechanical, Industrial or Biomedical engineering or related engineering field and 3 years of experience as an engineering program manager, process engineer, or an occupation in process engineering, or a Bachelor’s degree in Mechanical, Industrial or Biomedical Engineering or related engineering field and 5 years of experience as an engineering program manager, process engineer, or an occupation in process engineering. Must possess a minimum of 3 years of experience with each of the following: Process engineering for medical devices; ISO 9001, ISO13485, ISO 14971 and cGMP; Product Lifecycle Development; Product Lifecycle Management (PLM) tools including Agile, SAP, and QAD; DOE, SPC, QSR and IQ/OQ/PQ; Risk-based failure mode to include PFMEA and PFMECA; Microsoft Excel, Microsoft Project, and Minitab; Process characterization, Process Qualification, and Validation Protocols; and Lean and Six Sigma practices to include DMAIC process and root cause analysis, 5S, scrap reduction and yield improvements.

Relocation assistance is not available for this position.

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