6 month contract
Up to 72 an hour
Process Development develops and modifies process formulations, methods and controls to meet quality standards for the launch of the Robotic Platform. The Staff Engineer will help to develop and guide improvements or modifications to process development activities. The Staff Engineer would need to be able to detect potential problems in a process and direct the team in how to avoid them. More specifically the Staff Engineer will be responsible for the following: Working with Project Manager to complete process development deliverables Generate Validation documentation for new processes and route through change management system Review and Update project related Process Documentation such as pFMEAs and PCPs Focus on implementing process controls Write and Release Process Work Instructions related to assembly, inspection, and manufacturing Develop and complete Test Method Validation for new tools in Production and Receiving Inspection Support in the ordering and assembly of new Workstations for Operations Floor Program Torque Profile PSET for Torque Wrenches Write Process Validation and Equipment Qualification Plans and Protocols, especially for Manual Processes Conduct Process Validation and Equipment Qualification Process Studies
A bachelor’s degree in Mechanical, Industrial, or Systems Engineering or equivalent Minimum of 7 years of experience in a regulated manufacturing industry, preferably from Medical device, Aerospace, or Automotive Expertise with Large BOM Electromechanical Assemblies Expertise with creation and use of pFMEAs, PCPs Expertise facilitating collaboration amongst multi-disciplinary teams to drive complex troubleshooting, root cause analysis and issue resolution Expertise with Process Validation of both manual and automated processes Expertise with Test Method Validation, specifically Gage R&R and Attribute Agreement Studies. Expertise in troubleshooting and correcting issues that arise during validation activities Expertise with statistical analysis tools such as Minitab Expertise with Torque Profile PSET Programming Fluent with Microsoft Project, Word, Excel and Visio
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