Manufacturing Engineer - NPI

Emeryville, CA 94608 | Direct

Job ID: 7868 Category: Manufacturing Engineer

Qualifications:

  • BSME or MS in engineering (Mechanical, Electrical, Industrial, or Biomedical)
  • 3+ years of experience in product design - medical device design is a plus
  • Solidworks modeling or experience in comparable CAD
  • Experience with injection molded plastics/parts (ultrasonic welding, fastener-less assembly)
  • Experience with creating design documentation and common manufacturing practices
  • Familiarity with international standards and regulation for manufacturing

Responsibilities:

  • Contribute to all phases of product development - new product design, creating drawings and specs
  • Assist in creating manufacturing processes with quality and manufacturing teams
  • Build and troubleshoot prototype devices
  • Create design documentation, design reviews, product’s Design History File (DHF) and Device Master Record (DMR)
  • Compile data and generate reports for findings
new product introduction, injection molded plastic, design, test, ISO 13485, FDA

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