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Mechanical Design Engineer

Cincinnati, OH
Position Role/Tile: Mechanical Design Engineer
Location: Cincinnati, OH.


o             Hands on experience in design and  development
o             Hands on experience in FDA regulated Design Control, Change Control, NPD flow.
o             Good understanding of ISO 13485, 21 CFR Part 820 standards and risk management (ISO 14971)
o             Design-related experience and knowledge of general design engineering and DFMA principles, component manufacturing processes, tooling methodologies, material properties, and regulatory compliance
o             Experience in NPD of  Plastic/Metal components
o             Basic engineering (e.g., statistical techniques, validation protocol, process capability studies, process validation, developing solutions that meet quality, performance, and cost commitments).
o             Experience with CAD/CAM and design analysis software with a basic knowledge and understanding of medical regulatory requirements
o             Risk Management activities Proven ability to perform root cause investigations, and CAPA process
o             Writing technical documents is required
o             Expected to lead the engineering change projects with minimal support from client SMEs
o             Organizes and conducts Engineering builds

Central Business Solutions, Inc,
37600 Central Ct.
Suite #214
Newark, CA 94560
Central Business Solutions, Inc(A Certified Minority Owned Organization)
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Central Business Solutions, Inc
37600 Central Court Suite 214 Newark CA, 94560
Phone: (833)247-8800 Fax: (510)-740-3677

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