NPI Manufacturing Engineer

Manufacturing Engineer

Full-time Permanent

Location: Bothell, WA

Pay: DOE

Main Purpose of Job:

Assist with design and manufacture of new medical devices.

Main Job Duties & Responsibilities:

  • Work with the R&D and manufacturing team to define requirements and design product and processes to launch catheter based medical devices.
  • Create 3D Solid models and GD&T based production drawings of products.
  • Interface with Quality and Research and Development organizations to integrate new products or processes into the existing manufacturing area.
  • Lead, manage, implement and execute multiple projects to support product development, manufacturing process development and improvement on time and on budget.
  • Develop clear and well understood documentation which may include, but is not limited to, process and inspection procedures, protocols, deviations, drawings, and documentation.
  • Write and execute process validation protocols (IQ, OQ, PQ) and associated reports.
  • Provide necessary technical expertise associated with second tier supplier designs, manufacturing processes and supporting subsystems.
  • Document experiments, tests, and process development activities.
  • Train production trainers and assemblers on new or modified equipment/processes.
  • Develop and manage outside OEM services

 

Qualifications:

  • Bachelor’s degree in Engineering discipline plus 7 – 10 years of related experience in Product Development, Manufacturing Engineering and Product introduction.
  • Expertise medical device manufacturing following GMP, ISO 13485, MDD, and QSR requirements.
  • Experience in New Product Introduction
  • Diversified knowledge and experience in Process Qualification and Validation.
  • Strong background in change and configuration management.
  • Strong Technical writing abilities required.
  • Expertise in relevant materials fabrication equipment/techniques.
  • Experience in broad range of DfX categories
  • CAD capability, SolidWorks preferred.
  • Exceptional Interpersonal and communication skills.

 

 

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