Manufacturing Engineer I

Responsibilities may include the following: 

• Design manufacturing processes, procedures, and production layouts for assemblies, equipment installation, machining, and material handling
  
• Develop and optimize workflow and sequence of operations to improve efficiency and productivity
  
• Design equipment and facility layouts to maximize production capabilities
  
• Adapt machine and equipment designs to meet manufacturing and production requirements
  
• Incorporate inspection and testing requirements into production processes
  
• Evaluate equipment performance and implement corrective actions to resolve issues
  
• Support statistical process control (SPC) and continuous improvement initiatives
  
• Provide engineering support for design concepts and manufacturability
  
• Ensure compliance with FDA, ISO, and GMP regulations
  
• Collaborate with cross-functional teams including Quality, Operations, and R&D
  

*Other duties may be assigned.*

Requirements

• Bachelor’s Degree in Engineering (Mechanical, Electrical, Chemical, or related)
  
• 0–3 years of experience in manufacturing, engineering, or related roles
  
• Bilingual (English & Spanish)
  
• Experience in Computer System Validation (CSV)
  
• Experience working in a regulated environment (Medical Devices or Pharmaceutical industry)
  
• Basic knowledge of manufacturing processes and equipment
  
• Strong organizational, communication, and technical writing skills
  

Preferred: 

• Knowledge of Process Validation (IQ/OQ/PQ)
  
• Experience with Statistical Tools (Minitab or equivalent)
  
• Familiarity with MES systems (e.g., FactoryWorks)
  
• Knowledge of risk management tools (FMEA)
  

*Willing to work 100% On-Site, weekend and other shifts when necessary.*