Manufacturing Engineer

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.