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Project Engineer job in Irvine at Saviance Technolgies

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Job Requirements

  • Establishes appropriate team roles and responsibilities for activities at the site they represent and creates project plans to drive activities and technical transfer deliverables. The Project engineer engages the MTO and MS&T resources, guides them and coordinates the day to day activities that culminate in a successful transfer of the product, process, or project into the manufacturing environment. 
  • Designs, builds and validates custom fixtures and manufacturing documentation culminating in successful process validation and release to production. 
  • Works closely with R&D, purchasing, planning, line supervisors, manufacturing and quality engineers, supervises, monitors and ensures timely completion of all transfer activities. The Senior Project engineer works under the guidance and reports to the Technical Transfer Lead. 
  • Coordinates activities, reviews work product (design, documentation, validations, data) of temporary engineering staff, technical stewards, and validation engineers that are assigned to the product, process, or project being transferred. The technical transfer engineer participates in design reviews and engages the appropriate subject matter experts to ensure designs can be manufactured to specification, yield, reliability, and cost.

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Project Engineer at Saviance Technolgies

Project Engineer

Saviance Technolgies Irvine, CA Contractor
$50.00 - $55.00/Hour
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The Project Engineer operates in a matrix organization to transfer designs, products, technologies, equipment, and acquired company assets to the site and where applicable into production at the site. The Project Engineer is the primary contact on the transfer team and ensures that there is sufficient representation from the impacted areas.


Skills:

  • 3-8 years’ experience in Medical device in ISO-13485 environment preferred
  • 2-5 years’ experience in new product introductions/manufacturing/ manufacturing science and technology/technical development/quality/R&D
  • In depth understanding of manufacturing processes and related process equipment
  • 1-2 years of experience in executing process validation, transfer of products from R&D into manufacturing, and working on multidisciplinary teams that include all functions in the manufacturing environment.
  • Mechanical design experience using Solidworks or Creo.
  • Windchill and SAP experience a plus
  • This person must be able to critique designs for their manufacturability.
  • Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions).

Education:

  • BSc. in Engineering. Master of Science in Engineering preferred
  • Establishes appropriate team roles and responsibilities for activities at the site they represent and creates project plans to drive activities and technical transfer deliverables. The Project engineer engages the MTO and MS&T resources, guides them and coordinates the day to day activities that culminate in a successful transfer of the product, process, or project into the manufacturing environment. 
  • Designs, builds and validates custom fixtures and manufacturing documentation culminating in successful process validation and release to production. 
  • Works closely with R&D, purchasing, planning, line supervisors, manufacturing and quality engineers, supervises, monitors and ensures timely completion of all transfer activities. The Senior Project engineer works under the guidance and reports to the Technical Transfer Lead. 
  • Coordinates activities, reviews work product (design, documentation, validations, data) of temporary engineering staff, technical stewards, and validation engineers that are assigned to the product, process, or project being transferred. The technical transfer engineer participates in design reviews and engages the appropriate subject matter experts to ensure designs can be manufactured to specification, yield, reliability, and cost.

Recommended Skills

Engineering
Manufacturing
Medical Device
Project Engineer
Project Management
Windchill

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