Manufacturing Engineer II

Position Overview :

The Manufacturing Engineer II plans and designs manufacturing processes for a production facility. Maximizes efficiency by analyzing layout of equipment, workflow, assembly methods, and work force utilization. Being a Manufacturing Engineer II determines the parts, equipment, and tools needed to achieve manufacturing goals according to product specifications.

Responsibilities :

• Evaluate current catheter manufacturing practices and identify those needing improvement.
• Lead operations to increase production capacity and implement new efficient processes.
• Analyze and design sequence of operations and workflow to improve efficiencies and establish methods for maximum utilization of production facilities and personnel.
• Use Lean Manufacturing Methodology, including Value Stream Mapping and Kaizen events.
• Use Six Sigma Methodology (DMAIC or DMADV) and tools including Minitab, FMEA, Fishbone, Process Mapping, etc.
• Responsible for manufacturing process development, implementation, and continuous improvement to enhance yield, reduce cost and improve productivity.
• Represent Process Engineering in assigned R&D and Project Team meetings for technology transfers and provide technical expertise and support in analytical method development, validation and process scale, and current production capabilities in manufacturing.
• Performs or manages process validations (IQ, OQ, PQ).
• Troubleshoot production line issues related to yield, quality, and throughput.
• Leads scaling up processes from development to full scale manufacturing.
• Supports evaluation of NCR, CAPA, SCAR, Failure investigation and Deviation requests arising from Contract Manufacturers / Suppliers.
• Creates / Updates manufacturing instructions, routings, bills of materials and SOPs.

Qualifications : Education :

Required Experience :

Knowledge, Skills, and Abilities :