Mechanical Engineering Specialist

16 hours ago


Temecula, United States Indotronix Avani Group Full time

Location: Temecula, CA 92590 (Onsite)


RESPONSIBILITIES:

  • Authors test methods, test protocols, test method validations, and test reports with minimal supervision
  • Plans and performs experiments that support new product or technology feasibility testing.
  • Conducts testing as assigned applying appropriate test methods, protocols specifications and equipment (includes product and/or equipment testing).
  • Adheres to ZebraSci Quality Systems, including but not limited to; timely identification, and notification of potential Quality Events (e.g. OOS, Deviations, CAPA…) and the subsequent forward processing and investigation of such events.
  • Responsible to maintain the lab and storage areas in a clean and organized manner.

KNOWLEDGE AND SKILLS:

  • Knowledge of drug-device combination products and/or medical devices
  • Knowledge of the operation of mechanical measurement equipment (e.g. Instron, Zwick), vision systems (Keyence), and container closure integrity instrumentation
  • Experience with test method development and validations (MSA, Gage R&R, etc.) is desirable
  • Application of statistical and analytical methods such as Design of Experiments, ANOVA analysis, and statistical software (Minitab, JMP, etc.)
  • Knowledge of GLP, cGMPs, 21CFR820.30, ISO and ASTM procedures beneficial.

Education & Experience:

  • Bachelor’s or Master’s degree in Mechanical/Biomedical/Chemical or relevant engineering field plus relevant experience related to combination product or medical device development and/or testing:
  • 1-5 years of experience with a BS


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