Vinay M Email & Phone Number

United States

Franklin Lakes, New Jersey, Us

Franklin Lakes, New Jersey, Us

• Worked with the advanced drug delivery solutions team as a technical leader on a cross-functional project team through all phases of the project lifecycle, from concept through launch. • Represented the organization as the prime technical contact to a pharma partner on a B2B product development project.• Performed GSPR gap assessment and developed remediation plans, updated DHF and Techfile.• Developed experimental bench studies, tolerance stack up analysis, FMEAs, design verification, validation, vendor interactions, materials specifications, and component specifications to solve technical product development challenges.• Developed a framework to reduce product development cycles and quality via the application of DFSS and Lean Product Development Tools.

Abbott Park, Illinois, Us

•Developed strategies to update devices to the new EU MDR Class I, II and III requirements. • Worked closely with cross-functional teams to identify and mitigate technical issues to reduce programmatic risks on EU techfile submission for structural heart products. •Worked on new design verification test methods (TM), Test method Validation (TMV) and statistical techniques to analyze data effectively. •Worked on development and maintenance of product specifications, requirements documents, hazards analysis documents, usability and V&V documentation, and other technical documentation.

Warsaw, Indiana, Us

• Coordinating EU MDR activities for Design Controls Workstream. • Working on updating all documentation (Design History Files, Design Control documents, Verification/Validation documentation, and Risk Management files) in line with the General Safety and performance requirements specified within the MDR legislation in line with new product groupings. • Developing testing protocols for testing/analyzing the products to satisfy MDR 2017/745 performance requirements.

Warsaw, Indiana, Us

Warsaw, Indiana, Us

•Responsible to update User Needs, Design Inputs, Design Outputs, Risk Management, DFMEA, Design Verification & Validation (V&V) of Sports Medicine Implants and Instruments as per 21CFR 820.30, ISO 13485, ISO 14971- in the new design control electronic repository system.•Collaborated with cross functional teams of Development, Quality, Regulatory, Research Engineers to identify and update Design History Files (DHF). •Developed comprehensive protocols for Verification and Validation activities of soft tissue repair products and proposed resolutions to satisfy new Statistical Data Requirements per the quality standards using MiniTab. •Developed Finite Element Analysis models (FEA) for NPI products to understand the possible failure modes.•Created Tolerance stack-up and functional relationship analysis (FRA) template for the team, following the ASME Y14.5-2009 GD&T standards.•Feature Criticality Assessment (FCA) and control plan to reduce non-conforming products.

*Developed an automated testing robot for testing multiple clinical sample trays with no human interference using Arduino, and python code for data acquisition. *Developed concepts sketches and CAD designs of a consumer smartphone-based rapid diagnostic tests that transforms the standard clinical test into 15 minutes home based test.*Designed reflective optics and light pipes to enhance the performance of the system by 20% using Trace Pro.*Designed sample cartridges for the diagnostic test and made them cost efficient for soft tooling injection molding. *Extensively tested the low volume concept prototypes using hands-on prototyping & 3D printing techniques. Optimized GD&T of CAD Models for injection molding specifications. *New product development documentation and developing manufacturing drawings and bills of Material *Developed MATLAB code to process the clinical test images and export the data to analyze the performance.*Knowledge of clinical testing requirements and approval process for medical instruments by FDA.*Y-Combinator (Summer 2016)

Bengaluru, Karnataka, In

*Designed a Stereolithographic type consumer 3D Printer with high resolution printing capability.* Optimized the guide mechanism to reduce the inertia to achieve 30% higher gantry speeds with high precision and used the design for manufacturing (DFM) techniques to cut manufacturing time. *Sourced and procured the optical system for the machine.*Reviewed a variety of resins and tested curing time of the resin with various optic sizes. *Analyzed various materials and sheet metal manufacturing processes to manufacture the shell of the 3D printer http://fracktal.in/

Master Of Science (M.S.), Mechanical Engineering

Bachelor Of Engineering, Mechatronics, Robotics, And Automation Engineering

Master Of Business Administration - Mba