Process Validation Engineer (Medical Devices)

 

	
• Location : 100% ONSITE – Waltham, MA (02451)
  
  	

• Duration:  12 month contract – (extension potential)
  
  	

• Pay : Negotiable depending on DIRECT related experience Up to $45 – $50/hr
  
  	

• Type:  W2 contract ONLY – (C2C OR THIRD-PARTY arrangements will NOT be considered)
  
  	

• Work Authorization:  Must be currently located and authorized to work in the United States without sponsorship requirements.
  
  

 

 

	
• Strong understanding of medical device manufacturing process development, transfer, optimization, and validation (IQ/OQ/PQ).
  
  	

• Demonstrated experience supporting both internally developed and externally sourced manufacturing processes within regulated environments.
  
  	

• Solid foundation in statistical methods and data-driven problem solving, including DOE, process characterization, process capability analysis, and root cause investigation.
  
  	

• Proficient in use of Minitab, or similar statistical software.
  
  	

• Working knowledge of risk management and design control methodologies, including FMEA, control plans, and design transfer activities.
  
  	

• Experience with complex medical device manufacturing processes such as catheter assembly, balloon processing, laser processing, extrusion, thermal forming/heat setting, bonding, precision assembly, and/or injection molding preferred.
  
  	

• Familiarity with electro-mechanical and capital equipment manufacturing processes preferred.
  
  	

• Ability to troubleshoot complex manufacturing and process-related issues and implement effective corrective and preventive actions.
  
  	

• Ability to read, understand, and create engineering drawings using common engineering software, including GD&T interpretation for tight-tolerance components.
  
  	

• Ability to conduct complex statistical, geometric, and mathematical calculations.
  
  	

• Demonstrated project and task management skills across multiple concurrent initiatives.
  
  	

• Strong technical communication skills, including the ability to write and review protocols, reports, specifications, and technical documentation.
  
  

 

 

 

 

Important information:  To be immediately considered, please send an updated version of your resume to ....

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