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Cordis · 2 months ago

Manufacturing Engineer II (Second Shift)

Irvine, CA

Full-time

Onsite

Mid, Senior Level

$76K/yr - $102K/yr

5+ years exp

Cordis, in partnership with Selution, specializes in developing advanced drug device combination products for treating coronary and peripheral artery disease. The Manufacturing Engineer II will focus on the development, evaluation, and optimization of manufacturing processes, ensuring a robust transition from product development to full-rate production.

Health CareHealth DiagnosticsMedical

No H1B

U.S. Citizen Only

Responsibilities

Develop highly capable manufacturing processes for existing products in manufacturing. Ensure robust transition from product development thru full rate production ensuring process stabilization

Develop, and qualify new tooling and equipment

Update FMEA’s and QCP’s for NPI

Verification/Validation of processes, machines, and equipment to meet requirements of Company procedures. IQ/OQ/PQ protocols

Create and sustain routers and standards

Troubleshoot product/process related issues, perform root cause analysis to develop and implement corrective and preventative action plans

Interface with all internal organizations with supporting new product development, introductions, technologies, and supporting systems

Qualification

Class IIIIIb Implantable Medical Device experienceValidation/Verification process knowledgeFDA’s QSRGMP understanding’s Degree in Engineering5 years manufacturing experienceFluent in EnglishVerbal communicationWritten communicationOrganization skillsAttention to detailProblem solving skillsProject management skills