Manufacturing Engineer

Vibrant America LLC, 3521 Leonard Ct, Suite B, Santa Clara, CA 95054

Job Duties:

  • • Focus on manufacturing and biochip immunoassay research.
  • • Operate an ISO 13485 certified class 2 cleanroom.
  • • Optimize the workflow, inventory to reduce costs and implemented continuous improvement solutions.
  • • Build a network of suppliers, ensure quality of raw materials to efficiently plan manufacturing and meet demand.
  • • Develop diagnosis platforms for food allergies, rheumatoid arthritis, tickborne diseases, viral infections.
  • • Perform fabrication and testing of chip-based microarrays for in-vitro diagnostic medical devices.
  • • Implement polymers in process chemistry to increase yield of biomarkers on the chip and validated them using fluorescence microscopy.
  • • Assist in development of an in-house photoresist for the biochip platform.
  • • Work with specialists in the industry to find novel solutions for wafer processing.
  • • Develop chemistry to functionalize the wafer surface to house organic compounds.
  • • Develop new process to use macro/meso-porous silicon wafers to be used in the biochip ecosystem.
  • • Interface with the management, manufacturing, assembly, R&D teams to work towards company’s goals.
  • • Streamline manufacturing processes and boosted inventory by 400% for the lab test kits.
  • • Optimize assay reagent ingredients to improve shelf life and signal-to-noise ratio during biochip imaging.
  • • Develop validation protocols for the test kits and reagents.
  • • Author SOPs, maintenance protocols, QC documentation, implement and observe strict quality standards.
  • • Streamline documentation for quality control, batch records, in accordance with ISO standards.
  • • Write SOPs, training documents, and on-boarding manuals. Coordinate R&D for multiple projects.
  • • Set up process control plans, manufacturing protocols, quality controls that adhere to ISO 13485 quality standards to ensure that non-conformity is minimized, and throughput is maximized.
  • • Develop new process to extract proteins from food products for allergy testing.
  • • Vertically integrate the manufacturing process, utilize economies of scale to cut costs drastically.
  • • Seamlessly transfer protocols from research to production, ensuring no loss in quality or knowledge.
  • • Perform IQ/OQ/PQ for homogenizers, centrifuges, pipettes, balances and other lab equipment before laboratory usage.
  • • Optimize the workflow to transition between automated liquid handlers, microscopy for detection, data analysis.
  • • Achieve sensitivity and specificity above 90% in diagnostic test kits with automated liquid handlers.

  • Requirements:

Master’s degree in Mechanical Engineering, Manufacturing Engineering or related fields.

Required skills:

  • Knowledge of conventional and non-traditional manufacturing methods.
  • Knowledge of 3D and 2D CAD software.
  • Project experience with rapid prototyping for testing and analysis.
  • Project experience with composites, material selection to improve surface chemistry, material strength.
  • Project experience with software such as MS excel, python.
  • • Project experience with python to perform hardware-in-loop simulations and automation.
  • • Project experience employing supply chain management and inventory management.
  • • Project experience creating cost effective design for facilities.

Annual Salary: $107,702 – $120,000

Please submit your resume/application to