Manufacturing Engineer II (Second Shift)

Cordis • Irvine, CA

68d • $76,450 - $102,300

About The Position

Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.

Requirements

• Bachelor’s Degree in Engineering or related science discipline [required]
• Minimum 5 years of experience in a manufacturing environment
• Class III, IIb Implantable Medical Device experience
• Previous experience working in a clean room environment
• Strong verbal and written communication skills with ability to effectively communicate at multiple levels in the organization
• Strong organization and follow-up skills, as well as attention to detail
• Ability to take independent decisions
• Own project level goals involving multiple engineers
• Break down ambiguous tasks into clear milestones to ensure progress can be measured
• Knowledge of Validation/Verification process, Gage R&R, and a clear understanding of FDA’s QSR and GMP
• Strong analytical, problem solving, and project management skills
• Fluent in English

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.

What This Job Offers

• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees