Role: Manufacturing Engineer

Location: Irvine, California, United States

Duration: 10 Months on W2 (Contract only)

Shift Timings: 8 AM to 5 PM (Mon-Fri)

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 must-have. 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 full-time engineers in developing processes.

- Background in introducer/catheter processing is preferred.

Education and Experience:

- Bachelor's degree (Bio-Medical, 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.