
Satya Prakash Ojha
Project Engineer

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About me
Senior MDR Specialist | Medical Devices | Oil & Gas | CAD CAM Expert | MBA Project Management| Innovative Design Engineer|
Education

Baba Saheb Naik College Of Engineering
2005 - 2010Bachelor of Engineering (BE) Mechanical EngineeringActivities and Societies: Sports. Debates, Extempores Mechanical Engineering with First Division, Participated in Debates, paper presentation. Represented college in Cricket at University level

St. Joseph Senior Secondary School, Kanpur
2002 - 2005HSC ScienceActivities and Societies: Music, Sports, and Science HSC & SSC(Science)

Sikkim Manipal University - Distance Education
2015 - 2017Master of Business Administration - MBA Project ManagementMasters in project management as well as other project aspects.
Experience

Unique Mixers & Furnace Pvt. Ltd.
Sept 2010 - Mar 2012Project Engineer• Playing a key role in project planning.• Monitoring and coordinating allotment of project work to the team members.• Supervising development of solid model with the help of 2D layout.• Preparing job card and job scheduling according to the project priority on daily basis.• Efficiently drafting, detailing, section with BOM, GD & T, Machining Symbols, etc.• Design Calculations for the bullet mounds, tanks shell. Design GA, BOM as per the final equipment.• Fabrication of Process Equipment’s i.e. Sigma mixers, Planetary mixers, V Blenders, Heating Pumping unit, Ball mills, Plough shear mixer, Ribbon blender and small pressure containing vessels. Show less

Weatherford
Apr 2012 - Jan 2018Design Engineer• Working on Lower well completions and zonal isolation tools.• Performance Envelope and Feasibility Study for the Tool and Equipment for particular loading and pressure.• Engineering Drawings along with hand calculation supporting the designs.• Engineering Drawing, detailing, section with BOM, GD & T, Machining Symbols, etc for the tender drawings and manufacturing drawing and General Assembly Drawings.• Check Layouts and Feasibility drawing with options for design changes and material changes.• Detailed operational layouts for in depth analysis of component positions and its failure points.• Fabricating Operating Envelope for the desired packer in desired well condition to verify it. Stress and strain related calculation to cross check the usability of the assembly component and the safe functioning of the assembly.• Perform Design calculations like Stress, Bearing stress, Burst & collapse, Thread strength etc.• Product Scheduling and planning. Perform simple engineering tasks using established or new methodology.• Assure drawings are compliant to industry standards.• Reviews product design for compliance with engineering principles, applicable standards (ISO, API and ANSI), contract requirements and related specifications.• Complete Responsibility and handling for Design, Calculation, Bill Of• Material, Evaluation & Qualification of API 5CT, API 11D1, API SPEC 14L,• API Q1 and API 14a for safety valves cased hole and open hole.• Direct and coordinate manufacturing or building of prototype product.• Communication with the US based office and carrying out the work accordingly.• Locally traveling to manufacturing facilities Show less

HCL Technologies
Jan 2018 - Apr 2019Lead Engineer• Working on medical devices like Lab automation diagnostic systems for Siemens Healthineers as clients.• Creating Design History file as per the changes implemented.• Reviewing and approving design related documents like risk file, safety file etc.• Reporting the offshore project development to client.• Carrying out all design activities using CREO2, NX integrated with Teamcentre.• Preparing periodical report for project development and managing off shore resources inside the project.• PCI activities and project tracking using PM Smart project management tool.• Problem solving related to mechanical component on Automaton lines. Show less

TechnipFMC
Apr 2019 - Jun 2022Senior Engineer• Working on Subsea system like Umbilical hardware, UTA and Subsea systems.• Hand Calculations and Engineering Design Calculation of the loads and stress on various load bearing components.• Finite Element Analysis of the subsea hardware based on the load calculation.• Preparing, reviewing and approving design calculation .• Design changes to qualify the hardware for the loads and client specific requirement.• Calculation based on client agreed standards like DNV, API, Norsok etc.• Managing the team work and work load management as per deadlines.• Coordination with drafting team and the product engineers over the feasibility study of the hardware and its components.• Engineering Change Management for the release of new parts as well revising old parts.• Tracking project progress and coordinating between global locations regarding work flow and developing new skill sets for team and self.• Identifying and eliminating wastes and making work process leaner.• Tracking the competency of the team members and training them accordingly, thereby elevating the level of task based on competency rating. Also helps in proper utilization of the resources. Show less

Medtronic
Jun 2022 - nowSenior MDR SpecialistResponsible for evaluating complaints for medical devices across various portfolios like diabetes management, surgical innovations, cardiovascular, etc. Reporting complaints as per regulatory requirements to regulatory authorities such as the FDA, EU MDR, and other local regional authorities across the globe. Identifies complaint risk/investigation level based on reportability decisions made. Notifies investigators of reportability decision changes that would affect the investigation level initially established. Upon receipt of additional information that impacts the initial reportability decision & determines the effects of the initial reportability decision. Notifies country representatives of reported Confidential events that occurred outside of their country but involve products that are approved and registered in their country and their country. Creates and reviews the Alternative Summary Report for submission. Responsible for providing for eMDR/MedWatch Report and Health Canada Vigilance – Medical Device Reporting Program. Evaluate any modification, revision, and/or review of new complaint information for which a closed complaint may require reopening. Responsible for the maintenance of Reportability Guidance Document. Identifying reportability status based on new information received. Providing inputs to the new product development team based on complaint inputs. Distributing and managing workload to applicable team members and reviewing them. Show less
Licenses & Certifications

AutoCAD 2007

Pro-E Wildfire 3
Languages
- enEnglish
- hiHindi
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