Job Summary

Apply Lean Six-Sigma problem solving competence and aggressively drive to reduce waste in stretch blow molding and extrusion processes through data-driven engineering investigation: Design of Experiments; Root Cause Analysis, capability analysis, and utilization of other appropriate Quality Improvement tools. 

This engineer has a high level of broad blow molding competence gained through on-the-job expertise and/or is a high performing engineer with transferrable plastics processing skills to become quickly proficient in the operation of custom manufacturing equipment, testing & measuring instruments, and in processing various plastics to specification.

The Engineer III will drive multiple projects simultaneously and achieve business results in compliance with the Quality Management System and in an inclusive manner.   She/he work closely with customers, Operations, Quality, Skilled Technicians, Account Managers, Machine Shop and Senior Management.

Essential Job Duties and Responsibilities

• Support Quality System Management requirements, including:
• Change control
• NC, Customer Complaint, CA/PA investigation and resolution
• Process risk assessment, PFMEA
• Support customer / intercompany audits
• Compliance with Quality Management System, FDA Quality System Regulations, ISO Standards and SOP’s as defined by Nordson Medical’s policies, practices, and procedures
•  Review proposed product/process changes considering risk & customer notifications 
•  Train manufacturing and quality control personnel in understanding specifications, new product requirements, procedures, and measurement techniques.
• Methodical problem-solving competence to drive manufacturing engineering / development investigations, experiments, and resolutions across production Value-Streams
• Troubleshoot and permanently resolve process issues
• Perform activities in assigned areas, including: 
• • Waste reduction initiatives -Value Improvement Projects
  • Print/specification interpretation and capability assessment
  • Perform process, product and equipment validations / verifications
  • Implement proper data collection, analysis and action
  • Create, own, and execute projects from initiation through completion
  • Compile evidence and report status as required
  • KPI data collection and reporting
• Technical leadership competence: train, support and develop junior engineers
• Perform manufacturing engineering tasks, including
• Create Current State and Future State Lean Manufacturing Value stream maps
• Write/update production procedures
• Collect and analyze data for quality improvement
• Perform Root Cause Analysis
• Implement Statistical Process Control, Process Monitoring and Response
• Implement Standard Work
• Improve process / material flow
• Other duties as assigned by Senior Management

Education and Experience Requirements

• Bachelor’s Degree–Plastics Engineering, Materials Science-Plastics Engineering (preferred), other Engineering degrees (considered)
• In addition, production equipment / software expertise, MBA and/or project management skills are desirable.
• Knowledge, training, experience in medical device manufacturing & quality systems (ISO 13485; 21 CFR 820)
• 10+ years of experience