Manufacturing Engineer
4 weeks ago
Role: Manufacturing Engineer
Location: Irvine, California, United States
Duration: 6 Months on W2 (Contract only)
Skills Looking For:
- Setting up a new line which will end up being a commercial line and the plan is to get this line started in mid June.
- Experience in installing equipment and equipment troubleshooting, running installation qualifications is a musthave. This will be the main focus of the role.
- Must have experience working in a Cleanroom environment
- Medical device experience is required.
- Experience in other validation works will be a plus. Like execution of Process Validations including Test Method Validation (TMV), Inspection Method Validation (IMV).
- Experience in Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Product Performance Qualification (PPQ).
- Must have experience in writing and releasing IQ reports.
- Help other fulltime engineers in developing processes.
- Background in introducer/catheter processing is preferred.
Education and Experience:
- Bachelor's degree (BioMedical, Chemical, Mechanical engineering) with 3+ Years of experience is preferred.
- Candidates with 8 years of experience are also fine if they are willing to work at a given rate and have the desired experience.
- Masters degree is also fine if they have 2 years of medical device equipment installation and troubleshooting experience.
Top 3 Skills:
- Installation Qualification experience
- Med device experience.
- Equipment troubleshooting in installation.
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