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Manufacturing Engineer II  Eden Prairie, MN  Posted: 8/10/2020
Job Description

Job ID#:


Job Category:


Position Type:

Direct Only



$ 70000.00 - $ 80000.00

Manufacturing Engineer II
 SW Metro|  Direct Hire
Konik PrimeStaff is partnering with a growing medical device manufacturer in the SW metro that is seeking to add a Manufacturing Engineer to their team. In this role, you will get to work on manufacturing processes for critical, complex medical / pharmaceutical combination products for a global market. This will involve implementing, validating, and supporting important manufacturing equipment, fixtures, tools, and processes. This is an excellent, direct-hire opportunity in the medical device industry.
Manufacturing Engineer II Responsibilities:
  • Collaborate with product development on device designs to ensure manufacturability and automated packaging solutions
  • Translate design requirements into process and equipment requirements that meet Regulatory and Quality requirements
  • Collaborate on risk management activities such as FMEAs and process FMEAs
  • Develop, execute, and document equipment qualifications and process validations including IQ/OQ/PQ plans and reports
  • Perform Measurement system analysis (MSA) Gage repeatability and reproducibility (GRR), design of experiments (DOE), statistical process control (SPC), and capability analysis to develop, troubleshoot, and control processes
  • Support test method and inspection method development and validation used during design verification, process validation, and commercial manufacturing
  • Develop, implement, and support production documentation including manufacturing procedures, routers, and bill of materials (BOM)
  • Utilize tools including value stream mapping, overall equipment effectiveness, and 5S to understand and improve quality, labor efficiency, throughput, and cycle time
  • Provide engineering support to customers, equipment suppliers, and contract manufacturers
  • Provide project communication to team members, customers, contract manufacturers, and stakeholder
  • Support product complaint investigations and reports
  • Support CAPA/NCR/SCAR investigations and reports

Job Requirements


Manufacturing Engineer II Requirements:
  • Bachelor’s in Mechanical Engineering, Manufacturing Engineering, or equivalent
  • 3+ years of experience in the medical device, pharmaceutical, or related industry required
  • Experience with automated assembly processes and equipment validations and  
  • Knowledge of GMP, CFR, ISO, QSR, and other regulations
  • Experience with SolidWorks, Minitab, Microsoft Project/Excel/Word, or similar software
  • Excellent interpersonal and communication abilities
  • Great work ethic and a desire to learn and work in a busy work environment
  • Experience utilizing SolidWorks a benefit
  • Ability and willingness to travel around 10-20%
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 45 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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