Apply manufacturing engineering disciplines to support ongoing production processes. Will also drive: production issue root cause analysis and resolution initiatives, product and process performance improvements, and the reduction of manufacturing waste. Must be able to maintain multiple programs simultaneously.
Essential Job Duties and Responsibilities
Lead Manufacturing engineering activities across production Value-Streams, as assigned.
Lead Manufacturing engineering activities for assigned projects and in assigned areas.
Train and Support production personnel as required
Troubleshoot and resolve process issues using standard engineering problem solving methods
Resolve customer issues via calls or on-site visits
Perform or oversee in-house activities in assigned areas, including
Lead Waste reduction initiatives
Development to Production Transfer responsibilities
Process and equipment validations / verifications
data collection and analysis
Project management and reporting
KPI data collection and reporting
Perform or lead manufacturing engineering tasks, including
Write Production Procedures
Root Cause Analysis
Standard work implementation
Process / material flow
Lean Manufacturing Value stream improvements
process risk assessment, pFMEA
Product/ Process qualification
Statistical process control
Process monitoring implementation
data analysis for quality improvement
Engineering study, analysis and reporting
Support Quality/Production System requirements, including
process / procedure documentation development
CA/PA investigation, execution, verification, and implementation
Support customer / intercompany audits
environmental monitoring and controls
Assure compliance with FDA Quality System Regulation, ISO Standards and SOP's as defined by Nordson Medical's policies, practices, and procedures.
Review product and process changes to ensure proper documentation and actions related to risk assessment are complete.
Train manufacturing and quality control personnel in understanding specifications, new product, procedures and measurement techniques.
Other duties as assigned by the Director of Operations
Education and Experience Requirements
4-year degree in engineering or technical field; or equivalent training and experience
Knowledge, training, or experience in medical device manufacturing and quality systems (ISO 13485; 21 CFR 820)
4-10 years experience in:
Manufacturing Engineering (Medical Device is preferred)
Process development, DOE, ANOVA, process control
Environmental monitoring program
Lean/six sigma tools
Root Cause Analysis tools
Auto CAD and or Solidworks experience is preferred
Successful Lean/Waste reduction experience
Equipment/ Process Validation
Skills and Abilities
Good writing and personal communication skills
Must be well organized and focused
Execution and results focused
Computer skills required
Disciplined data driven engineering approach towards solving problems
Working Conditions and Physical Demands
Nordson Corporation provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status or any other status protected by applicable federal, state, or local law.
All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.