V V N R Rao Kandregula Email & Phone Number

Hyderabad, Telangana, India

• Effectively handling a team of 20 people.• Responsible for end-to-end execution and delivery of NPD projects which involve Requirement analysis, Design, Development, Integration, V&V, Quality. Regulatory, Product compliance and release the product to market.• Conducting and completing phase gate deliverables PDR, CDR, FDR and SA for NPD process and Starting and Closing deliverables for bug fix maintenance projects. • Assign and review the tasks to team and cross functional teams. Scheduling the cross functional team calls weekly to monitor the progress of the project. • Responsible for conducting and documenting the CCBs and updated in Azure DevOps for the bugs raised and field complaints received.• Point of contact for PMO for India R&D center.• Responsible for acting as independent reviewer for other PMs projects delivered throughout Global.• Hands on experience on Agile PLM management tool to release all controlled versions.• Updating and maintaining the design and development planning documents i.e PRD, MRD, HWRS and SWRS in Telelogic DOORS 9.6 tool for inflight and NPD projects• Scheduling the weekly updates and bi-weekly dashboard updates with the senior management. Participating in the portfolio updates with presales team throughout the global about inflight and new product development project releases.• Lead product Risk management process (Risk Analysis, Risk Estimation, Risk Evaluation, Risk control and review control measures) as per EN ISO 14971:2019.• Supporting and participating in internal and external audits and providing the solutions and CAPA process to NCs received during the audit and conducting project audits in accordance with the Project’s Quality Plan.

Hyderabad, Telangana, India

• Lead product Risk management process (Risk Analysis, Risk Estimation, Risk Evaluation, Risk control and review control measures) as per EN ISO 14971:2019• Hands on experience Agile PLM on ECO changes for process and product related documents• Preparing product design related proposal documentation like DHF and DMR as per ISO 13485, 21 CFR 820 requirements.• Good network of contacts with global certification test laboratories like TUV Rheinland, UL, INTERTEK WIPRO Tarang and CSA on product compliance testing.• Drive strategy for managing the Medical Affairs approach to compliance with EU MDR including gap assessments which includes GSPR, Technical documentation, standards map assessment and PMS assessments. Creating remediation plans and leading the DHF remediation. • Supporting in MDSAP audit for the clients supports the regulatory and quality requirements for member countries FDA, TGA, ANVISA, MHLW/PMDA and Health Canada (USA, Australia, Brazil, Japan and Canada).• Product Software requirements, maintenance, risk analysis, verification and configuration management as per SDLC IEC 62304.• System Reliability Test Plan Preparation as per requirements of product System Requirements Specification.• Experienced in FMEA with R&D Engineer during module development which included Analysis of De-rating of components, process analysis etc.• Leading the product compliance certification for Spacelab’s Healthcare instruments.• Leading the team to complete the RoHS 3 compliance as per EU 2015/863 regulations.• Work as Subject matter expert in reviewing the cross functional team Engineering Change Orders • Cross Functional Team Management - Production, Design Engineering, Supply Chain & QA-RA Team, Regulatory Affairs.

Chennai Area, India

• Good experience project monitoring, preparing and reviewing of project estimation, proposal and SOW. • Drive strategy for managing the Medical Affairs approach to compliance with EU IVDR including gap assessments which includes GSPR, Technical documentation, standards map assessment and PMS assessments. Creating remediation plans and leading the DHF remediation.• Lead a team handling regulatory transition activities from IVDD to IVDR for different clients.• Work as Subject Matter expert in EU IVDR to collaborate with other functional and cross-function associates working on compliance with EU IVDR• Integrate/create a set of control structures for Medical/Clinical EU IVDR activities including processes, procedures and associated accountabilities to ensure consistent governance and quality assurance.• Prepare technical files for submission to European Notified Bodies for CE marking of new and modified products, with input from support functions (R&D, Quality, Manufacturing, etc.).• Supporting in compilation of documentation for 510(k) submission and CE marking.

Hyderabad Area, India

Key Result Areas: • Design Review of electronic circuits and prepare test plan for validation of EMI/EMC & ENV testing of electronics components in instruments.• Supporting complete product compliance certification for Biogenex Lifesciences products with test labs TUV Rheinland, UL, Intertek and CSA.• Leading the team to complete the RoHS 3 compliance as per EU 2015/863.• Work as Subject matter expert in reviewing the cross functional team Engineering Change Orders • Cross Functional Team Management - Production, Design Engineering, Supply Chain & QA-RA Team, Regulatory Affairs.• Supporting and participating in Material review board with cross functional teams and providing the solutions from the engineering team on supplier escalations received on inward materials.• Preparing the product Documentation as per ISO 13485, 21 CFR 820 requirements and maintaining the product DHF folders.• Scheduling the internal audits for the cross functional teams.

Hyderabad Area, India

Key Result Areas: • EMI/EMC and Safety testing of prototypes of new designs from the test labs Intertek, TUV Rheinland, UL and CSA.• Responsible of our Prototype compliance testing with certified bodies like TUV, UL, INTERTEK etc.,• Involved in schematic entry design, component selection, BOM creation and online component ordering.• Creating product related proposal documentation and datasheets.• Analyzing test requirements and involved in preparing the hardware test plan and protocols required.• Providing customer/technical support activity via internet/emails• Assisting IQC engineers in FAI for Electrical and Electronics Parts and supporting to IQC in closure of material under MRB from Engineering - Electronics side.

Hyderabad Area, India

Key Result Areas • Responsible for troubleshooting & functional testing of: o PCB cards, Gyro Stabilised Horizontal Roll Bar System (GSHB)o Electronic Lock Control Unit (ELCU) and involved in Installation of these units in the containers at the site• Prepared schematic diagrams by using PROTEL Tool and Bill of Material (BOM)• Performed documentation for electronics engineering projects.• Gained experience of working with different types of oscilloscopes and troubleshooting of electronic circuits• Accountable for testing and verification of specifications of new subsystems of main instruments• Involved in testing, calibration, customer complaint analysis, process analysis and final quality testing.• Accountable for assembly (Soldering) of components on PCB board.

Hyderabad Area, India

Key Result Areas:• Involved in schematic entry design, component selection, BOM creation and online component ordering• Providing basic PCB layout guidance to layout engineer• Accountable for PCB soldering up to SMD0603 and ICs with 1mm pitch SMD components• Creating product related proposal documentation and datasheet• Analyzing test requirements and involved in executing basic test cases tracking of bugs• Rendering support to software team in board bring-up and driver development• Assisting online support to field application engineers • Providing customer/technical support activity via internet/emails

Bachelor Of Technology (B.Tech.), Electronics And Communications Engineering

Graduation from JNTU, Hyderabad

Diploma, Electronics And Communication Engineering

State Board of Technical Education and Training