Job Description

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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