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Principal Mechanical Engineer

San Francisco, CA 94080

Employment Type: Direct Category: Mechanical Engineer Job Number: 10365 Pay Rate: $150K - $200K

Job Description

Qualifications:
  • BSME, 15+ years of working experience
  • Experience in design of biotech or medical consumables/disposables
  • Extensive experience in plastic injection molding process, knowledge of tooling design, materials, material properties, DFM
  • Familiarity with FDA quality requirements (ISO 13485, cGMP, QMS standards, USP class VI (biocompatibility testing))
  • Proficiency in SolidWorks CAD
  • Experience in designing test fixtures to support V&V
  • Ability to travel to vendor locations overseas as needed
Responsibilities:
  • Responsible for the design, development, prototyping, and volume manufacturing of complex injection molded assemblies and high-precision mechanical components & assemblies
  • Specifying injection molding tooling with state-of-the-art capabilities: Variotherm, vacuum assist, hot runners, etc
  • Design and development of manufacturing test fixtures as required
  • Identify & interface with key component vendors (suppliers of tubing, valves, etc., that may be integrated into our consumable design)
  • Interface with R&D systems & mechanical engineering teams to negotiate designs that meet product requirements & are feasible to manufacture economically

 

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