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Manufacturing Engineer II

  • Specialty:

  • Title:

    Manufacturing Engineer II
    • City:

      Maple Grove
    • State:

    • Zip Code:

  • Start date:

  • Status:

  • Assignment Type:

    Direct Hire
  • Job Id:



Responsible for documenting, implementing, and improving the manufacturing processes. Lead process verification/validation activities. Lead cross functional projects; assure activities are completed within prescribed schedules and efficiently utilize resources. Identify, construct and implement improvements to process or design. Provide training to production operators and other manufacturing personnel. Provide work direction to technicians and lead others as required.     

Primary Duties and Responsibilities:    

  • Plans, directs, and coordinates manufacturing development activities around design or processes for medical device assembly and service  
  • Provides management of projects chartered to improving manufacturing methods or design  
  • Strong familiarity with statistical methods and terminology.  
  • Frequently participates or leads a team concerning product design and selection of tooling, vendors, materials, etc. to ensure efficient production methods are selected and the product meets the requirements  
  • Expert representative on a project, product, and/or process development activity who brings forth the utilization of GMP and design for manufacturing methodologies to assure and improve efficiencies and product designs  
  • Supports the manufacturing operation on a daily basis to ensure production of product   
  • Troubleshoots design or process issues, implements improvements, and supports all other daily activities such as NCMR (non-conforming material review), re-work, and implementation of change orders  
  • Analyzes processes and creates methods for process and quality monitoring including development of and reporting of metrics   
  • Serves as project manager for sub-categories of larger initiatives or programs 
  • Provides leadership (technical and project) to manufacturing technician staff to assure initiatives are met in accordance to broader scope: 
  • Writes documentation to define a product or process fully for use in a regulated environment.   
  • Writes clear and detailed test protocols and reports.  
  • Provides expert reference to technical resources (technicians, engineers and assemblers) to assure drawings, work instructions, methods are fully defined and validated and able to be effectively conveyed to the production staff  

Preferred Qualifications

· BS in Mechanical, Chemical, or Biomedical Engineering or relevant degree

· 3-5 years of experience as a manufacturing engineer in a medical device environment 

· Experience with and knowledge of nitinol processing 

· Demonstrated ability to model in Solidworks, ProE, or Creo.  

· Demonstrated expertise in a variety of process technologies and manufacturing environments 

· Demonstrated leadership experience or operated in a leadership capacity (e.g.; production lead, problem solving) in a manufacturing environment minimum 2 years 

· Demonstrated ability to perform job duties of all subordinate positions while working with operators who are ESOL (English as a second language) 


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