Manufacturing Engineer II

• Design manufacturing processes, procedures, and production layouts for assemblies, equipment installation, machining, processing, and material handling.
  
  
• Design and optimize equipment and machine arrangements within plant facilities to improve productivity and workflow efficiency.
  
  
• Define and sequence manufacturing operations, including fabrication of tools and equipment impacting product performance.
  
  
• Adapt machine and equipment designs to factory and production conditions.
  
  
• Incorporate inspection and testing requirements into manufacturing and production plans.
  
  
• Inspect machinery, equipment, and tools to verify performance and efficiency; investigate issues and initiate corrective actions to ensure product quality.
  
  
• Develop and support manufacturing processes compatible with Statistical Process Control (SPC).
  
  
• Provide technical guidance to engineering teams regarding design concepts, specifications, and optimal use of manufacturing equipment and techniques.
  
  
• Ensure all processes, procedures, and documentation comply with applicable regulatory requirements.
  
  
• Perform other duties as assigned.*
  

Requirements

• Minimum of 2 years of relevant experience in a regulated industry (medical device, pharmaceutical, or similar).
  

• Experience with process validation, equipment validation, and computer software validation (CSV).
  

• Bachelor’s degree in Engineering completed
  

• Ability to manage Supplier Change Requests.
  

• Strong collaboration and teamwork skills with adaptability to changing project requirements.
  

• Strong problem-solving skills and a continuous improvement mindset.
  

• High attention to detail and commitment to quality and compliance.
  

• Strong written and verbal communication skills in English and Spanish.
  

Technical Skills

Must Have:

• Process Validation knowledge
  

• Computer Software Validation (CSV)
  

• Equipment Validation
  

• Supplier Change Request management
  

Nice to Have:​

• Experience with sterilization methods:
  

  • Ethylene Oxide (EO)
    

  • Steam
    

  • Liquid chemical
    

  • Radiation
    

• Experience with non-sterile packaging or pharmaceutical packaging design