Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
• Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
• Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
• Adapts machine or equipment design to factory and production conditions.
• May incorporate inspection and test requirements into the production plan.
Nice to Have
• Understanding of Lean Manufacturing, and Six Sigma, certification preferred (Green Belt, Black Belt)
• Experience in medical device manufacturing or technology preferred.
• Project Management Certification (PMP) or at least working knowledge of project management techniques.
• Experience in FDA 21 CFR Part 820 Medical Device Manufacturing, or ISO 13485.
• Experience in Statistical methodologies; DOE, SPC, etc.
• Experience with risk management, including but not limited to Process Failure Mode Effects Analysis (pFMEA), Design Failure Mode Effects Analysis (dFMEA), fault tree analysis, or other risk management tools.