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NPI Engineer

Location: Brooklyn Park, Minnesota Salary: competitive
Sector: Medical Devices, Engineering, Engineering, Mechanical, Test and Verification Type: Contract

Summary:

The NPI Engineer will be a high-performing individual that will drive the development of Medical Device manufacturing processes from prototype assembly to production manufacturing. The desired individual will possess a broad range of Medical Device design and development skill and experience, as well as depth of knowledge of process development, process validation, lean manufacturing methodology, and statistical process control.

Responsibilities:

  • Develop and document manufacturing processes for Medical Devices
  • Drive process design and product design for manufacturability to ensure robust and capable manufacturing processes
  • Plan and execute assemble, documentation and qualification of the manufacturing line
  • Plan and execute process characterization studies to determine optimal process windows
  • Design and procure process equipment, tooling, fixtures, and assembly aids
  • Implement process improvements and controls to reduce assembly time and drive yield improvements
  • Conduct process risk analysis for products under development and implement process controls to drive risk mitigation's
  • Plan and execute process validations including IQ, OQ, PQ and PPQ activities
  • Ensure that all work satisfies the requirements of the company's Quality Manual, with a particular emphasis on Design Control

Education:

  • Bachelor's Degree in Mechanical Engineering, Bio-medical Engineering or Manufacturing Engineering is required
  • Master's degree in engineering, management or business is desired

Skills:

  • At least 3-5 years of Medical Device product and process development
  • SolidWorks 3D CAD proficiency
  • Demonstrated ability to bring products from concept to market
  • Knowledge of probability and statistics

Sthree US is acting as an Employment Business in relation to this vacancy.