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Manufacturing Engineer
Location:  Northern Suburbs, Minneapolis, MN 
Recruiter Name:  Jen Anderson
Phone:  (651) 697-2123
Job ID:  15576
Category:  Mechanical/Manufacturing/Quality Engineering
Job Type:  Direct Only
Minimum Experience:  0-2
Required Education:  Bachelor of Science
Salary:  $ 60000.00 - $ 70000.00
Job Description
Manufacturing Engineer
 
The manufacturing engineer in this role will assist in the process development, qualification and manufacturing of medical devices and industrial manufacturing at a Twin Cities manufacturing company.  The Manufacturing Engineer is responsible for supporting the team with programs, procedures, and systems that deliver products that consistently meet or exceed customer and regulatory requirements.  Additional responsibilities of the manufacturing engineer include improving current manufacturing processes and procedures, developing manufacturing plans and documentation to support new products, facilitate efficient operations within the production area to ensure production goals are met; analyze and solve problems from basic engineering principles, theories and concepts through to a wide range of complex and advanced problems.
 
Manufacturing Engineer Responsibilities:
  • Assist in the process development and qualification of the manufacturing of medical devices
  • Write detailed production documentation
  • Evaluate existing manufacturing processes through design, applying knowledge of product design, fabrication, assembly, tooling, and materials.
  • Develop manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment.
  • Improve manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout.
  • Assure product and process quality by designing testing methods; testing finished goods, determining product and process capabilities; establishing standards; confirming manufacturing processes.
  • Provide manufacturing decision-making information by calculating production, labor, and material costs; reviewing production schedules & estimating future requirements.
  • Maintain compliance with FDA, ISO9001 and ISO13485 regulations.
  • Develop statistical methods of quality control.
  • Apply FMEA process to evaluate failure data, if necessary, from field data to find root cause and implement sound engineering solutions
  • Support validation in all manufacturing processes per FDA requirements for medical equipment
  • Identify opportunities for cost reduction; implement process and product improvements to achieve cost reduction goals
  • Ensure proper documentation is completed to meet quality systems requirements. Write and review validation protocols and reports applicable to new processes
Job Requirements

Manufacturing Engineer Requirements

  • Knows and applies fundamental concepts, practices and procedures of a variety of manufacturing practices including lean manufacturing.  (manufacturing cost structures, cycle time studies, line balancing, level loading, constraint management, labor and equipment capacity analyses, value stream mapping, SMED among others)
  • Understanding of process validation concepts and practices including, IQ, DOE, OQ, PQ and PPQ
  • Basic understanding of ISO Quality System requirements and FDA regulations
  • Experience or knowledge of root cause of technical issues and ability to implement solutions
  • Solid knowledge of engineering fundamentals; ability to apply this knowledge to manufacturing and product
  • Strong attention to detail
  • Must be well organized.
  • Strong documentation skills. The ability to write complex documentation is required.
  • Proficient with MS Office applications
  • Good understanding of statistics, trigonometry and algebra
  • Basic mechanical design skills.
  • Solid written and verbal communication skills.
  • Some light travel may be required.

EDUCATION:

  • Bachelor of Science in Mechanical Engineering, Manufacturing Engineering, or similar required

Konik PrimeStaff is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as a qualified individual with a disability, or any other protected class status.

 
Konik PrimeStaff has been a leader in the technical staffing industry for more than 40 years, providing the fastest and easiest link between employees and employers. Konik PrimeStaff has specialized in placing professional, qualified personnel in Minnesota and western Wisconsin businesses since its inception and maintains a strong commitment to customer service.


 


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