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Staff Mechanical Engineer

San Francisco, CA 94080

Employment Type: Direct Category: Mechanical Engineer Job Number: 10376 Pay Rate: $150K - $210K

Job Description

 
  • BS/MS Mechanical Engineering, 12+ years of experience in biotech automation or semiconductor process equipment industries
  • SWx, GD&T, Python
  • ISO, FDA, cGMP, QMS (regulatory requirements and documentation)
  • Broad experience in complex mechanical systems for material handling (mechanisms), temperature control, fluid handling and dispensing, optical & optomechanical systems
  • Experience with laboratory automation is preferred
  • Strong familiarity with manufacturing processes such as precision machining, injection molding

Responsibilities:
  • Responsible for the design, development, and prototyping of mechanical components and consumables used in mechanical sub-systems & complex biotech instruments
  • Design and development of automated test fixtures to validate the reliability and robustness of novel components
  • Interface with systems & mechanical engineering teams to negotiate designs that meet product requirements & are feasible to manufacture economically
  • Conduct design reviews and present fresh ideas, new technologies, and creative solutions to design problems
  • Define subsystem architecture
  • Show proof of concept through rapid prototyping
  • Ability to extract design requirements from a broad spectrum of user needs
  • Identify potential design risks and provide a path to derisk/pivot rapidly
  • Work closely with the scientific team through the creation of verification /validation protocols (IQ, OQ, PQ) and successful execution, data generation, report and documentation
  • Create comprehensive work instructions and manufacturing SOPs as needed for finished designs

 

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