Process Improvement Engineer

1 week ago


Santa Clara, California, United States Dawar Consulting Full time
Process Development Engineer

Key Responsibilities:
  • Deliver hands-on support for process troubleshooting and enhancement initiatives.
  • Develop and validate Work Instructions, Production Records, and related documentation for operational processes.
  • Provide recommendations for process enhancements and ensure that controls are validated through method or system validation.
  • Lead or assist in investigations related to non-compliance issues, including Corrective and Preventative Actions and Non-Conformance Reports.
Qualifications and Skills:
  • Bachelor's degree in a relevant discipline.
  • 5-8 years of experience in the Medical Device or In Vitro Diagnostics sectors.
  • Preferred experience in cartridge production, microfluidic technology, or DNA sequencing.
  • Experience in process mapping, documentation development, and testing within production settings is highly advantageous.
  • Strong skills in statistical analysis, Design of Experiments (DOE), and familiarity with tools such as Minitab for data analysis and interpretation.
  • Experience in raw material evaluation, including visual inspections, chemical assessments, and surface analysis.
  • Expertise in process validation, equipment validation, and ensuring adherence to applicable standards and regulations.
Company Benefits: Comprehensive Medical, Dental, Vision coverage, Paid Sick Leave, 401K plan.

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