Product Development Engineer(Must Have Medical Device Exp)

Company: MILLENNIUMSOFT
Location: El Paso
Posted on: March 17, 2023

Job Description:

Position : Product Development Engineer(Must Have Medical Device Exp)

Location : El Paso, TX

Duration : 12 Months Contract

Start Time - - - - - - - : 7:00 AM

End Time - - - - - - - - : 4:00 PM

Total Hours/week : 40.00



Description:

• 
  
• Product Engineering is responsible for transfer and scale-up of new products, developing iterations, modifying, implementing and supporting existing products that function within the product families through adherence to established design control processes and good engineering practices.
  
  
  
  
  What is expected of you for success in your role:
  
  
  • 
    
  • Demonstrates advanced knowledge of Engineering principles in solving moderately complex problems
    
  • Demonstrates advanced knowledge of product design and development
    
  • Independently tests, analyzes, and solves technical problems
    
  • Applies advanced statistical techniques and utilizes design of experiments
    
  • Independently verifies design inputs and establishes appropriate design outputs and qualifies designs
    
  • Interfaces with and selects suppliers that meet technical criteria
    
  • Responsible for development and scale up of new production lines the product follow applicable quality system regulations.
    
  • Responsible for the maintenance of the Design History Files for the Infection Prevention products.
    
  • Must have a working knowledge of Design Control for Medical Devices and Guidelines for Drug Development.
    
  • Experience with Design Transfer, Authoring and Execution of protocols, IQ,OQ,PQ, Risk Management documents, creation of Manufacturing SOP, RMS, Batch Records, Inspection Plans, etc.
    
    
    
    
    Qualifications:
    
    
    • 
      
    • Bachelor's degree in Mechanical, Biomedical Engineering preferred
      
    • A minimum of 2+ years related work experience required
      
    • Background in a highly regulating work environment required (Medical Device or Pharma strongly preferred)
      
    • Experience working in a manufacturing environment
      

Keywords: MILLENNIUMSOFT, El Paso , Product Development Engineer(Must Have Medical Device Exp), Healthcare , El Paso, Texas