Senior Process Engineer

US-CA-Rancho Santa Margarita

Overview

As a Senior Process Engineer, you will use skills related to sustaining and improving production manufacturing processes as part of a cross-functional team.


Responsibilities


Provide guidance on and complete the following:



  • Lead projects to develop and sustain manufacturing processes

  • Debug manufacturing processes and equipment via root cause analysis

  • Run, observe and expedite shop orders

  • Develop and review engineering documents such as process maps, process FMEA, Manufacturing/Quality Instructions, test methods, drawings, and test reports

  • Investigate materials, manufacturing processes and technologies

  • Research and qualify new suppliers and vendors

  • Review and evaluate non-conforming materials, address customer experience reports, perform root cause analysis, and propose corrective/preventative actions

  • Provide technical guidance to other team members and train as necessary on manufacturing documentation, prototype generation and data analysis

  • Identify project critical paths in order to define project priorities and manage resources

  • Develop contingency plans for alternative project paths as necessary

  • Collaborate with the Production team to identify capabilities and capacity

  • Collaborate with the Engineering team for fixturing and tooling design, tolerancing, and design for manufacturing

Position Requirements

This position requires the following skills and attributes:



  • 5+ years of relevant Engineering work experience

  • Bachelor’s degree in Mechanical, Biomedical, Industrial, or Manufacturing Engineering (or equivalent) 

  • Extensive experience with manufacturing equipment and processes

  • Extensive experience with computer-aided design (i.e. SolidWorks), spreadsheets, scheduling programs, and word processing

  • Experience with technical writing



  • Experience with Statistical Process Control (SPC)

  • Working knowledge of Geometric Dimensioning and Tolerancing (GD&T)



  • Knowledgeable about a variety of materials and mechanical designs

  • Ability to effectively manage projects and work in cross-functional teams

  • Excellent written and verbal communication skills and ability to effectively present information

  • Technical aptitude and detail oriented 


 


Preferred Qualifications




    • Experience in the medical device industry

    • Understanding of manufacturing and quality standards, including FDA regulations and ISO quality systems

    • Experience with software such as NetWeaver/Product Lifecycle Management




  • Experience with Minitab or other statistical analysis software

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