Nakul Ravikumar Email & Phone Number

San Diego, Ca, Us

- Successfully led projects from initial research and concept development through design, testing, validation, FDA 510(k) approval, and manufacturing of resorbable protective film products using MAST® WetGrip MicroSurface™ Technology- Modified existing customer products by ensuring compliance with design control procedures and relevant standards- Directed end-to-end product development in a regulated environment, conducted DFM, and implemented various manufacturing techniques including 3D Printing, CNC Machining, Injection Molding, thin film Extrusion, Embossing, Laser Cutting, and silicone processing- Executed IQ, OQ, PQ, and provided engineering support for production ramp-up, training, and documentation- Created, SOPs, work instructions, forms, LHRs, and material specifications- Organized and maintained product drawings and specifications for Design History Files and Technical Files of class II and III medical devices sold both domestically and internationally- Ensured compliance with ISO 13485, FDA Title 21 CFR, and EU MDR throughout the product development lifecycle- Coordinated with cross-functional teams including manufacturing, logistics, and marketing teams to plan and execute R&D projects, and conduct market research to evaluate similar products- Managed project timelines, budget planning, and prospecting of potential R&D projects with senior management- Established and directed product development teams, provided technical expertise, hired and trained staff, managed daily workflows, and conducted performance evaluations

San Diego, Ca, Us

- Established the internal R&D department at MAST Biosurgery- Acquired equipment and infrastructure to support R&D and production cleanroom scale-up- Identified and documented user needs, conducted risk assessments, and developed design input specifications based on customer needs, and regulatory requirements- Conducted design verification and product validation to ensure design outputs meet user needs through simulated use testing, pre-clinical, and clinical trials- Designed experiments, created test protocols, and generated detailed reports to support product development and regulatory submissions- Designed and developed laser-cutting fixtures with external manufacturers- Utilized SolidWorks to create MAST Biosurgery specifications and drawings for product, packaging, tooling, and assembly.- Layout planning and equipment compliance for ISO Class 7 and ISO Class 8 clean rooms- Maintained meticulous documentation of design processes and conformed to FDA Quality System Regulations (cGMP) and ISO 9001 standards

Greenville, Sc, Us

ISO 9001:2015- Responsible for developing and implementing annual QMS training (ISO 9001:2015 standard), lean manufacturing principles and root cause analysis, conducting regular QMS meetings, risk assessment(FMEA), and internal audits.- Responsible for organizing quality management meetings, creation of documentation, maintaining work instructions, control documents, and other routine procedures.- Problem solving and corrective actions using 8D, define quality objectives and measure monthly KPIs- Setup, alignment, calibration and maintenance of micro CNC, Keyence laser, custom friction testing equipment and measurement tools.

Greenville, Sc, Us

- Expertise implementing Hoowaki micro-surface technology in product development of medical, tooling, packaging applications.- Led problem solving projects within medical, tooling and automotive OEMs to reduce cycle time and cost on assembly lines.- Successfully led surgical barrier film project from development to production scale up at customer facility.- Spearheaded project implementing Hoowaki grip technology on implantable stents, results; reduced migration rate by 25+%.- Involved in fabrication, application and installation of micro structured surfaces within 10um tolerance on mechanical tooling to eliminate chemical coating processes.- Micro texture fabrication using EDM, Micro-CNC, Injection Molding, Extrusion, Blow molding, Silicon micro fabrication process and stereolithography. - Expertise in material handling, fabrication, and manufacturing feasibility of micro-surfaces on various polymers using injection molding.- Project management and planning using OmniPlan software module- Regular communication with Hoowaki sales and marketing team to help with scale-up of Hoowaki products

Clemson, Sc, Us

Mechanics of Seahorse Tails- Micro-CT scans of seahorses are carried out followed by computational modeling (using SolidWorks and other micro-CTanalysis software) to help explain the mechanisms behind the prehensility of seahorse tails- Overall goal of this research is to design search-and-rescue robots and biomedical devices that mimic seahorse tails- Secured 2nd place in ‘Science as Art’ exhibition conducted by Clemson University for a virtual seahorse tail display

Clemson, Sc, Us

- The lab covered topics like Programmable Logic Controllers, Computer Numerical Control machines, coupled dynamicsystems, heat transfer, and fatigue analysis- It consisted of 15~20 students who actively explored the topics with an open-ended approach

Clemson, Sc, Us

Graduate Thesis: Design and Development of an Optically-Based Strain Measuring Orthopaedic Screw for Fracture Fixation Implants- Developed a unique portable tool to quantify bone healing in lieu of quantitative assessments based on pain and radiography- Worked on the design of strain measuring orthopedic screw using SolidWorks® and development and testing (Instron® testingsystem) of the novel non-invasive tool to monitor fracture healing with the help of luminescent strain gauges- Worked on MATLAB® programming for image processing, post-processing and interpretation of the acquired data

Chicago, Il, Us

Requisition/ NPI support on PD Change order process for MSD, Propulsion & OHV domains.

Undergraduate Thesis: Fifth Wheel Parallel Parker - Worked on the concept design using CATIA® with the objective to improve efficiency of parking spaces - Secured third place in National Level Student Project Exhibition conducted by M S Ramaiah Institute of Technology for the project - Volunteer in design and fabrication of Trike automobile project using CATIA®

Paint Shop Conveyors.3D Modeling and Analysis of a Paint Shop Conveyor used to hold the front of a truck for the purpose of painting.

The role of tool design and its importance in an Industry.Under the guidance of Mr. A. R. Venkatnarayana, Retired Scientist and Head of Tool Design department, National Aerospace Laboratories (NAL), studied the effect of Jigs and Fixtures in reduction of cycle time and improvement of ease of assembly; this was incorporated to design a simple Drill Jig.

MFF Department - Manufacturing, Calibration & Testing of Fuel Injection Pumps.Worked in the manufacturing process & flow diagram of PDM Pumps & PF Pumps to decipher a quality related problem to which a solution was proposed at end of the internship.

Masters Degree, Mechanical Engineering, Design For Manufacturing (Dm)

Bachelor Of Science (Bs), Mechanical Engineering

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Education record