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Staff Mechanical Engineer
Posted on 2/22/2023
San Bruno, CA, USA
Experience Level
Desired Skills
  • BS or MS in Mechanical Engineering, Mechatronics Engineering, or equivalent experience
  • 11+ years of extensive, hands-on experience in the semiconductor, biotech automation, or similar industries
  • Excellent verbal, written, presentation and interpersonal skills
  • Strong analytical and problem-solving skills
  • Knowledge and/or hands-on experience with machine shop tools a plus
  • Knowledge of GD&T as well as strong proficiency with SolidWorks
  • Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks
  • Work history with several successful iterations of highly automated instrument design and development (biotech industry experience preferred)
  • Desire to be part of a rapidly evolving organization, with a compelling technology, and taking products and processes to the next level
  • Some experience with python, or high level scripting software languages, a plus
  • Self-awareness, integrity, authenticity, and a growth mindset
  • Responsible for the design, development, and prototyping of mechanical components & complex biotech instruments and mechanical sub-systems
  • Design and development of automated test fixtures to validate 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 rapidly de-risk/pivot
  • Work closely with the scientific team through the creation of verification /validation protocols (IQ,OQ,PQ) as well as successful execution, data generation, report and documentation
  • Create comprehensive work instructions and manufacturing SOP's as needed for finished designs
Desired Qualifications
  • Prior experience with FDA regulations and ISO, cGMP, QMS standards is a plus

51-200 employees

Cell therapy solutions