Yash Agarwal Email & Phone Number

New Haven, Ct, Us

Deep River, Ct

• Successfully launched class II medical devices – ASTRA TEE and ASTRA VR.• Provide technical expertise to Operations, Manufacturing, Technical Support and Field Service.• Sustaining engineering for class I medical devices - GUS products and storage cabinets.• Define and implement product improvements with additional 510(k), software updates and hardware improvements.

Deep River, Ct

• Successfully obtained 510(k) approvals for class II medical devices – ASTRA TEE and ASTRA VR.• Worked with quality to implement QMS system from scratch, obtain ISO 13485 approval for the company and successfully complete ISO audits.• Developed from scratch, complete product documentation including detailed product requirements, specifications, drawings, risk analysis, software testing, manufacturing work instructions, BOMs etc.• Setup product manufacturing cells, workflow and successfully completed Process Validation/Design Transfer.• Executed product design changes for improving product reliability, ease of serviceability and manufacturability and market launch.• Responsible for technical support to sales, marketing, field support and customer service.

• Managed operations and logistics for domestic and international customer base with a lean customer service department. Customer satisfaction survey reported high satisfaction rate. • Negotiated service contracts and executed a successful price increase/cost reduction strategy to increase annual service revenues and make service department more profitable. • Implemented an electronic customer call tracking system. Output of the system fed into engineering and quality systems to help with field issue tracking and drive engineering changes to decrease system downtime.• Provided input for new product development from customer interactions, which helped in repeat and new sales with increase in revenue. Offered technical assistance to sales personnel. • Ensured new products met quality and customer requirements before deploying them in the field. • Trained all FS personnel as per requirements and maintained training records.

• Successfully advocated bringing manufacturing in house to help improve product quality.• Worked in the Operations group, assuming the role of ME to setup in-house manufacturing. • Planned and implemented detailed processes from sub assemblies to system integration, testing, packaging, shipping, change control (ECN), non conforming material, variance etc.• Created comprehensive manufacturing drawings, BOMs, material specifications, assembly, test and field procedures, DHF, DHR following GMP guidelines. • Trained personnel in system assembly, testing, shipping, installation and customer support.• Worked with engineering to make design improvements to the system including fabricating a new enclosure from artist concept to a functional enclosure within the proposed timeline. • Co-ordinated with the different vendors to fabricate and acquire parts, negotiate pricing, monitor timelines and delivery.• Resolved production floor issues by creating hardware, software, documentation solutions and personnel training. • Worked with cross functional teams to design and complete verifications/validations of design changes.• Routinely transferred hardware and software design changes from engineering to manufacturing. Authored 100+ ECNs and involved in approval/implementation of 250+ ECNs.• Successfully spearheaded electrical & safety testing of the redesigned system to CE mark it. • Assisted QA in the successful approval of three 510k FDA applications.• Responsible for successfully releasing via ECN a CE marked IVD product with a reagent kit.• Served as in house product specialist and regularly provided customer support and assisted in field operations.

• Developed engineering specifications for an automated electro-opto-mechanical fluorescence microscopy system called Ikoniscope®.• Evaluated components such as frame grabbers, digital cameras, optics, XY stages, computers etc from different vendors to complete the prototype of the system.• Developed software for motion control and imaging (auto focus, auto exposure, image analysis etc).• Lead the process of hardware and software integration and calibration of the microscopes.• Worked on site with manufacturer in Europe to refine the pre-production system, design an enclosure & package it. • Successfully managed production and delivery of market ready systems as per schedule. • Served as the technical lead for obtaining TUV and CE marks. Assisted with regulatory (ISO, FDA) approval processes. • Created and maintained documentation like parts inventory, flowcharts, engineering drawings, schematics, assembly and test procedures, work instructions, manuals, IQ/OQ, QOP etc.• Planned and managed shipments, system installations, technical support and clinical user training. • Successfully conducted several product demonstrations to customers and at trade shows. • Trained and mentored personnel in Ikoniscope® hardware assembly, operation, testing, troubleshooting and maintenance.• Monitored system performance and developed enhancements as per customer feedback.• Devoted time to supporting computer infrastructure in the company.

Ms, Bioengineering

Be, Biomedical Engineering