Manufacturing Engineer

Role: Manufacturing Engineer

Location: Irvine California United States

Duration: 10 Months on W2 (Contract only)

Shift Timings: 8 AM to 5 PM (MonFri)

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:

Bachelors degree (BioMedical Chemical Mechanical engineering) with 3 Years of experience is preferred.

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.