Role: Manufacturing Engineer I

Location: Pleasanton, CA

Duration: 12+ Months(Contract)

Job Description:

• Execution of Process Validations including Test Method Validation (TMV), Inspection Method and Fixture design
• Validation (IMV), Installation Qualification (IQ), Operational Qualification (OQ), Performance
• Qualification (PQ), Product Performance Qualification (PPQ)
• Write and release IQ reports
• Troubleshoot process equipment
• Assist in developing processes based on product specifications and in consideration to
• Process and test method capabilities.
• Understand work environment issues (i.e. OSHA regulations, etc.).

Required Qualifications:

• B.S. in engineering
• 4+ years experience in process development or manufacturing process engineering
• Experience developing and validating medical device manufacturing equipment, fixtures, and
• Technologies with an emphasis on design for manufacturability (DFM) preferred.
• Experience performing installation qualifications (IQ).