Role : ManufacturingEngineer
Location : IrvineCalifornia United States
Duration : 10 Months on W2 (Contractonly)
Shift Timings : 8 AM to5 PM (MonFri)
Skills Looking For :
Setting up a new line which will end up being a commercial line andthe plan is to get this line started in mid June.
Experience in installing equipment and equipmenttroubleshooting running installation qualifications is a musthave.This will be the main focus of the role.
Musthave experience working in a Cleanroom environment
Medical device experience is required.
Experience in other validation works will be a plus. Likeexecution of Process Validations including Test Method Validation(TMV) Inspection Method Validation (IMV).
Experience in Installation Qualification (IQ) OperationalQualification (OQ) Performance Qualification (PQ) and ProductPerformance Qualification (PPQ).
Must haveexperience in writing and releasing IQ reports.
Help other fulltime engineers in developing processes.
Background in introducer / catheter processing ispreferred.
Education and Experience :
Bachelors degree (BioMedical Chemical Mechanicalengineering) with 3 Years of experience is preferred.
Masters degree is also fine if they have 2 years ofmedical device equipment installation and troubleshootingexperience.
Top 3Skills :
Installation Qualificationexperience
Med device experience.
Equipment troubleshooting in installation.
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