Projects & Experience

Led system-level testing for an insulin pump’s FDA 510(k) submission, ensuring accuracy and compliance with regulatory standards. Managed environmental monitoring for precision insulin dosing, supporting investigational studies on occlusion detection and dosing accuracy.

Developed and executed IQ, OQ, and PQ protocols for manufacturing of insulin pump and disposable connectors ensuring consistent, high-quality production.

Led verification and validation activities  for automated inspection equipment of disposable connector, improving defect detection and reducing quality risks.

Led the transfer of critical manufacturing processes to Contract Manufacturing Organizations (CMOs), ensuring seamless scale-up while maintaining compliance with quality and regulatory standards.

Conducted a cost analysis for high-impact capacity increase projects, presenting recommendations to senior leadership that resulted in improved production efficiency and reduced operational costs.

Led cross-functional project teams, managing deliverables across R&D, Quality, and Supply Chain to ensure successful product launches.

Managed prototype manufacturing with suppliers, overseeing timelines, quality standards, and technical collaboration.

Directed supplier selection and validation projects, conducting cost analyses to support senior executive decision-making.

 Defined hardware and system requirements for a water purification device in an at-home dialysis machine, ensuring optimal functionality and compliance.

Developed and executed feasibility test protocols at component, subsystem, and system levels to verify performance and reliability.

Drafted and executed IQ/OQ/PQ protocols, ensuring systems meet regulatory and operational standards.

Designed and tested microfluidic device prototype to isolate exosomes from plasma, utilizing soft-lithography and plasma bonding techniques. 

Applied microfluidic and lab-on-chip technologies to enhance diagnostics and therapeutic applications.