Position: Associate

Job type: Full-time

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Job content

The ideal candidate possesses both a high level of technical expertise and an innate passion to build. You will play a critical role in creating and refining processes in order to improve manufacturing safety, quality, and productivity.

You will have the responsibility to support and continuously improve current manufacturing processes, through technical and process innovation for the manufacture of neurovascular medical devices that save patient lives.

Responsibilities

  • Daily work includes both sustaining and project work –complete the types of projects that remove the need for sustaining work – improving safety, quality, output and eliminating scrap.
  • Provide support to the Manufacturing organization to facilitate efficient operations within the production area, to optimize existing processes, and to ensure that production goals are met. Further, monitor performance of equipment, machines and tools and corrects equipment problems or process parameters that produce non-conforming products, low yields or product quality issues. Interface with Quality and Research and Development organizations to integrate new products or processes into the existing manufacturing area.
  • Process validation and verification work is frequently required – knowledge of Process Validation Plans, IQ, OQ, PQ, Software validation, test method validation, gage R&R, and a clear understanding of FDA’s QSR and cGMP, and a good understanding in statistics.

Qualifications

  • Four-year degree required, preferably in Engineering.
  • Class III, IIb Implantable Medical Device Experience
  • Typical experience required is 3-5 years as an Engineer in a related field.
  • Deep process validation knowledge and medical device or pharmaceutical experience is required.
  • Line Layouts
  • Equipment Qualification
  • Statistical analysis skill set is required
  • Neurovascular experience is a plus
  • Strong background in metals, plastics, extrusion, and/or adhesives is highly desired.
  • SolidWorks, Nicelabel, and Statgraphics proficiency are highly desired.
  • Microsoft Project, Microsoft Visio, and Microsoft Access proficiency are highly desired.
  • A demonstrated ability to plan and run projects is highly desired.
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Deadline: 05-05-2024

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