• Currently analyzing the inter-reader variation of an in-vitro diagnostic point of care reader by collecting data on reflectance standards

• Led a team to perform a series of small experiments identified by why-why analysis & cause and effect analysis

• Managed and completed the data collection and analysis project using a PERT chart

• Managing the AdexusDx Analyzer project schedule using a Gantt Chart and estimated schedule delay using burndown charts caused due to a series of unanticipated R&D experiments

• Revised various test verification protocols and verification record template for Quality Management System

• Created risk management safety planning document and a complete set of files in the risk management process.

• Identified and evaluated Initial Hazards for the product and the project.

• Lead the risk management team. Identified, evaluated, controlled, and mitigated risks using Fault Tree Analysis, FMEA, and documented it in a Risk Analysis Table.

• Participated in the review of software input requirements, use case model, and software detailed design documents.

• Designed and developed optical stack parts of the AdexusDx Analyzer by working with industrial designers to accommodate ADEXUSDx blood-based hCG test cassette

• Recommended design improvements and created test procedures to minimize inter-reader coefficient of variation

• Led the team on the development of next-generation DxSCAN device by translating the voice of the customer, overall system requirements, and customer feedback to create design requirements (Input) and design specifications (Output). This ongoing reader device design can accommodate any size of the test cassette.

• Managed the development and manufacturing of the AdexusDx Analyzer with the plastic injection molding process, additive manufacturing, die-cutting, and laser cutting process

• Worked on transfer from R&D to manufacturing for the device by creating engineering specifications, drawings, bill of materials and cost analysis documents

• Created design and development documents, system requirement documents, specification documents, production processes, SOP, design control documents aligned with ISO 13485:2016 guidelines

• Managed the development team in line with quality engineering to pass the ISO Audit

• Actively analyzed and investigated medical device complaints and drafted the RMA process flowchart

• Implemented corrective and preventive actions and closed open CAPA resulted due to non-conformance

• Established the purchasing process including acceptance criteria with knowledge of FDA and ISO guidelines

• Designed and developed a functional prototype of encasings to hold electrical PCB for the product

• Assisted in the development and manufacturing of the final product with the injection molding process

• Coordinated the transition from development to mass production at external CMs and OEMs

• Developed work instructions and manufacturing procedures to support product manufacturing

• Managed packaging process to carry and store the product along with designing crosslink foam insert

• Developed packaging protocols to ease final boxing process and product shipment

• Supported operations team with vendor management

• Mentored junior team members and reviewed product testing and validation reports

• Prepared Validation Protocols for Design, Operation and Best Practice of Equilibrium product.

• Developed a requisition request platform to manage inventory

• Built and Executed Test Validation Cases for Firmware Validation and Mobile Application