Iso 11607 Jobs in Kentucky (NOW HIRING)

The Packaging Engineer III will own and drive packaging related deliverables, including new development, design changes, and process improvements through adherence to established design control processes, good engineering and documentation practices. The key responsibility of this position is to exercise medical device packaging subject matter expertise, sound judgement, and initiative while adhering to defined procedures during project support & improvements.

This role is 100% onsite at our Dublin, OH manufacturing facility.

• Immediate expectations
  
  
  
  • Responsible for the development and analysis of sterile or non-sterile barrier components and assemblies for medical devices
  
  
  • Fully participate in and successfully contribute to project teams typically including the following activities: packaging/product design and development, test of materials, preparation of specifications, process capability studies, report preparation, and process/test documentation – including PFMEAS
  
  
  • Initiate and lead proposed packaging design changes, systematically and thoroughly analyzed through proper justification and/or data collection for verification of performance requirements with adherence to program-management guidelines
  
  
  • Work independently to plan and schedule own activities necessary to meet project timelines
  
  
  • Work cross-functionally with project management, quality, R&D, manufacturing engineering, regulatory, operations, label designers, and marketing to ensure project success
  
  
  • Work with external suppliers to design, qualify, and procure packaging components
  
  
  • Complete packaging testing and/or investigatory bench study experiments for commercial design improvements
  
  
  • Own and manage CAPA tasks and deliverables (Corrective and Preventive) as assigned
  
  
  • Assist in vendor assessment and review of materials/machine technical information
  
  
  • Identify and implement process and product modifications to improve manufacturability and profitability
  
  
  • Consult with Operations and Quality Engineers on in-process packaging related non-conformances
  
  
  • Packaging material and design technical expert for multiple packaging configuration types
  
  
  • Assisting in creating and editing labeling templates, and implementation of those changes to documents to support Production
  
  
  • Receives general project direction. Responsible for project progress.
  
  
  • Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration. Brings substantive conflicts and disagreements into the open and attempts to resolve them collaboratively; builds consensus
  
  
  • Work on special projects as they arise
  
  
  
  


• Longer term expectations
  
  
  
  • Spearhead initiatives for continuous process improvements
  
  
  • Develop a broad understanding from start to end of the product packaging manufacturing process in the company
  
  
  • Perform design assessments, active participation in design reviews and risk management processes
  
  
  • Network with senior internal and external personnel
  
  
  • Manages training new/current employees with respect to documentation, use of equipment, laboratory techniques and department procedures.
  
  
  
  

• Proficient with ISO 13485, FDA Design Control, CAPA, SCAR, and audit procedures


• Proficient in packaging engineering, structured problem solving, use of statistical tools


• Proficient knowledge of external packaging standards and methods such as ISO 11607-1, ISO 11607-2, ASTM D4169, etc.


• Knowledge of the Medical Device Industry and familiarity with FDA QSR regulations


• Solid works knowledge to interpret part dimensions, sectional views, interface with product or components, and tolerance analysis

• Bachelor’s degree from an accredited college or university (Engineering or Technology), preferably in Packaging Engineering


• 5+ years of experience

• This job operates in a professional office environment and routinely uses standard office equipment with frequent work performed in a clean room environment.


• While performing the duties of this job, the employee may be required to sit or stand for long periods of time.


• Must be able to occasionally move and lift objects of up to 25 lbs


• Typically requires travel less than 5% of the time