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SUMMARY OF THE JOB

The Process Development Engineer designs, develops and optimizes manufacturing processes for design transfer to the production facility. Maximizes efficiency by analyzing equipment selection, characterization of process, process workflow, and fixture development. A Product Development Engineer optimizes parts, equipment, and tools needed to achieve manufacturing goals according to product specifications ahead of design transfer activities.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Evaluate current catheter manufacturing practices and identify those needing improvement.
• Lead process development and optimization activities with Design for Manufacturing in mind.
• Seamlessly interface between R&D and Manufacturing.
• Draft design transfer documentation for multiple lines.
• 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 operator dependency.
• 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, OQ, PQ).
• Troubleshoot production line issues related to yield, quality, and throughput.
• Leads scaling up processes from development to full scale manufacturing.
• Creates/Updates manufacturing instructions, routings, bills of materials and SOPs.

REQUIRED EDUCATION/TRAINING and/or EXPERIENCE:

• Bachelor's degree in a scientific/engineering discipline; or equivalent combination of education and experience.
• Minimum 5 years of experience in medical device (catheter experience preferred).
• Minimum 5 years of Process Engineering experience.
• Working knowledge of mechanical design principles and FDA regulated medical device design controls a plus.
• Proficient in CAD software, preferably SolidWorks.
• 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:

• Proficient in Risk Management according to ISO 14971.
• 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.