Manufacturing Engineer

Location: Minneapolis, Minnesota
Date Posted: 08-01-2017
Responsibilities 
  • Works within an integrated team to provide medical device product and manufacturing subject matter expertise to advance products from concept to production.
  • Take ownership for the design and development of process, with emphasis toward designs that enhance or improve and reduce cost
  • Assist and lend expertise in problem solving activities on existing production activities.
  • Recommends material specifications/standards for use in manufacturing 
  • Apply Lean manufacturing techniques to continuously improve cycle times and process flows. Identifies, and supports the execution of process improvement efforts
  • Applies statistical analysis techniques to quantify current process capabilities
  • Participate in Design Reviews, DFMEAs, FMEAs and periodic status review meetings on new programs 
  • Interpret production drawings using GD&T and how to properly apply it to yield the desired fits between joining parts
  • Assist investigation of device failures to determine root cause and corrective action
  • Assist process development activities, write work instructions, and develop in process inspection procedures
 
Requirements
  • Candidate must possess a minimum of a Bachelor's or advanced degree in Engineering.   
  • Thorough knowledge of quality systems, Quality by Design, validation, design transfer, and quality engineering principles for devices and combination products
  • Thorough knowledge of industry standards and FDA/EMEA regulatory guidance on combination products and medical devices, specializing in auto injectors
  • Strong communication skills both verbal and written
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