Description Terumo Medical Corporation is seeking a hands-on Product Engineer with 3-5 years experience in the manufacture of medical devices.

Responsibilities:

1. 
   

   Design, develop, implement and maintain manufacturing processes for disposable medical devices

   
   


2. 
   

   Characterize and select materials for the manufacture of disposable medical devices

   
   


3. 
   

   Investigate and implement process modifications and material changes to improve quality, increase yield/efficiency or reduce manufacturing cost

   
   


4. 
   

   Validate materials and processes in accordance with FDA standards

   
   


5. 
   

   Collect and analyze data to determine areas for process improvement

   
   


6. 
   

   Troubleshoot and resolve manufacturing issues

   
   


7. 
   

   Work with Product Development group to support products recently transferred into manufacturing

   
   


8. 
   

   Write product evaluation protocols, perform product testing and author engineering reports

   
   


9. 
   

   Gathering, tracking, and analyzing production data for meetings, business plan, etc. (yields/output/efficiencies).

   
   


10. 
    

    Plan work schedules, expenditures, attend meetings, and preparation of monthly reports are required 1

    
    


11. 
    

    Maintain and follow proper ISO procedures and GMP requirements

    
    

     

    
    

     

    
    

    Position Requirements

    
    

    1. 3-5 years of experience in the medical device industry

    
    

    2. Ability to identify root causes of problems and implement effective corrective actions

    
    

    3. Ability to proactively identify and resolve materials & process risks

    
    

    4. Strong interpersonal and organizational skills, the ability to work effectively with vendors/customers, and as a team member

    
    

    5. Demonstrated technical expertise in the manufacture of medical devices in automated and manual assembly environments

    
    

    6. Thorough knowledge of FDA process validations, including development of protocols and execution of protocols.

    
    

    7. Excellent communication skills both verbal and written , formal and informal

    
    

    8. Experience with Six Sigma, 5S, Lean principles, DOE, SPC preferred

    
    

     

    
    

     

    
    

    Educational Requirements

    
    

    Requires a 4 year degree in engineering, typically Mechanical Engineering, Materials Science or Chemical Engineering, Biomedical Engineering Six Sigma training is highly preferred. Solidworks training is a plus.

    
    

     

    
    

    About the Organization

    
    

    Terumo Medical Corporation is firmly committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of age, race, color, gender, national origin, religion, disability, protected veteran status and other protected classifications.