Cordis · 1 month ago
Manufacturing Engineer II (Third Shift)
Cordis is a company that specializes in the development of advanced drug device combination products for the treatment of coronary and peripheral artery disease. They are seeking a Manufacturing Engineer II to develop, evaluate, and optimize manufacturing processes and methods while ensuring robust transition from product development to full rate production.
Health CareHealth DiagnosticsMedical
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
Required
Bachelor's Degree in Engineering or related science discipline [required]
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
Company
Cordis
Cordis Corporation, a Johnson & Johnson company, has pioneered less invasive treatments for vascular disease.
Funding
Current Stage
Late StageTotal Funding
unknown2021-03-12Acquired
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