Manufacturing Engineer II (First Shift)

Cordis • Irvine, CA

7d

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. The Manufacturing Engineer II will be responsible for the development, evaluation, and optimization of manufacturing processes and methods, utilizing knowledge of product design, materials, fabrication processes, tooling, equipment, and quality control standards.

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

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees