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:
• Engineering degree desired or equivalent experience in related job field.
Required Experience:
• 2+ yrs Biomedical product or medical device development experience.
• Working knowledge of mechanical design principles and FDA regulated medical device design controls a plus.
• Proficient in CAD software, preferably SolidWorks.
• Familiarity with statistical analysis of raw data is required, proficiency in Minitab is preferred.
• Hands-on experience managing suppliers and/or contract manufacturers a plus.
• Familiarity with design control according to 21 CFR 820 or ISO 13485, engineering change orders (ECO), Corrective Actions and Preventive Actions (CAPA) preferred.
Knowledge, Skills, and Abilities:
• Knowledge of ASME Y14.5 GD&T.
• Excellent interpersonal, communication, and documentation skills are required.
• Takes initiative and acts quickly to drive solutions.
• Strong interpersonal, organizational and communication skills.
• A flexible team player, focusing on shared goals with a positive results‐oriented attitude.
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