| | | 20,000+ Fresh Resumes Monthly | |
|
|
| |
Click here or scroll down to respond to this candidateCandidate's Name
E: EMAIL AVAILABLE M: PHONE NUMBER AVAILABLEhttps://LINKEDIN LINK AVAILABLEProfessional Summary:7+ years of experience in leading Software Development Processes, quality assurance for Software as a Medical Device (SaMD), conducting software risk assessments, and implementing mitigation strategies following ISO 14971 in compliance with IEC 62304 and IEC 82304.Skilled in managing risk management plans, hazard analysis, performing FMEA for software-related risks throughout product lifecycle, New Product Development (NPD) processes, establishing systems engineering practices to verify design requirements.Proficient in developing & executing V&V test plans, ensuring SDLC alignment with FDA, ISO, and IEC standards, managing risk reviews, quality assurance activities, preparing for regulatory audits, maintaining post-market surveillance plans, analyzing product complaints.Design, and QA methodologies (STLC) to ensure the Quality Control, Risk and Safety for Class II and Class III medical devices in compliance with FDA QSR 820, ISO 13485, ISO 14971, FDA Validation guidance and IEC PHONE NUMBER AVAILABLE and GAMP-5 Computer System Validation (CSV).Highly proficient with all the phases of SDLC (System Development Life Cycle), Validation methodologies and Concepts of Qualification documents.Working experience in authoring requirements, documents corresponding to FMEA, Equipment verification plans.Expertise in Incident, Notice of Event (NOE) and OOS investigation database management.Experience in Data Migration, Periodic Review, GAP Analysis, Risk Analysis, CAPAs and Remediation process.Expertise in developing and documenting all the aspects in line with FDA medical device regulations and IEC PHONE NUMBER AVAILABLE and ISO 13485.Experience in developing and reviewing User Requirement Specifications (URS), Functional Requirement Specifications (FRS).Well versed with FDA regulations like CFR Part 820, Part 210 & 211.Good exposure to Validation Waterfall and Agile methodology.Skills:Hardware EquipmentDUAL Catheters and OFDI/IVUS Catheters, Oscilloscope, Multimeter, VGA, Angio, Waveform generator.Validation21CFR Part 820, cGXP, SOP, Remediation Plans, RTM, Validation deliverables Infrastructure validation, Non-conformancesProgramming LanguagesC++, C#, Java, NetCore, SQL.Scripting LanguagesPowerShell, Python and ShellToolsHelix ALM, Surround, Jama, Jira and Enterprise ArchitectureOperating SystemLinux, Windows IoT.Work Experience:Abbott Laboratories, Maple Grove, MN Mar 2024 PresentSenior Software Quality AssuranceLed quality assurance for Software as a Medical Device (SaMD), including conducting software risk assessments, implementing risk mitigation strategies following ISO 14971, in compliance with IEC 62304 and IEC 82304.Managed development of risk management plans, performed hazard analysis, and conducted Failure Modes and Effects Analysis (FMEA) for software-related risks throughout the product lifecycle.Established systems engineering processes to verify design requirements, critical to quality (CTQ) matrices, and ensure compliance with regulatory standards during product development.Developed and executed validation and verification (V&V) test plans, protocols, and reports for both hardware and software components, ensured SDLC aligns with FDA, ISO, and IEC requirements, and verified systems and design requirements to meet regulatory compliance.Conducted risk reviews, managed quality assurance activities, and preparation for regulatory audits and inspections, in compliance with FDA regulations, ISO 13485, and IEC standards.Maintained and updated risk management documentation, post-market surveillance plans, and compliance reports to address potential issues and product complaints.Analyzed product complaints and potential future issues, leading post-market surveillance efforts to monitor product safety and performance, conducted regular risk assessments and reviews to drive continuous improvement.Experience in the reviews of pre-defined deliverables/activities as identified in the SWQA Non-Product Quality Process and SWQA Product Quality Process/project plan.Experience ensuring documentation accuracy, clarity, consistency, completeness, and compliance for multiple projects. Including System Specifications/Requirements documents, Verification Test Cases, Verification/Validation protocols, Trace Matrices, and Verification/Validation Summary Reports.Experience reviewing the Test cases for pre and post-approval in TOSCAExperience in reports unexpected events, issues, or software bugs that occur during verification/validation to the project team and management.Developed and maintained departmental operating procedures to ensure compliance to relevant FDA QSR, ISO guidelines, including 21 CFR Part 11 and Abbott Corporate requirements as they relate to the development, verification, validation, and maintenance of computerized systems used in the Quality System as well as those used in the development of ADC Abbott and Lingo software/firmware productACIST Medical Systems, Eden Prairie, MNSenior Software Quality Engineer Jun 2023 Mar 2024Project: Nucleo/Horizon, Digital HealthDeveloped design verification test cases at system and function levels.Managed the execution of design verification dry runs and formal runs.Created protocol documentation for the test cases and requirements per ISO 13485.Experience in documenting Control Plan, FMEA, CAPA, and Validation per ISO 13485.Collaborated with cross-functional teams.Experience in creating and composing Requirements Traceability Matrix (RTM).Experience in BLE testing, validation, and troubleshooting to ensure reliable wireless communication.Experience in Equipment verification, more digital connectivity and charging technologies USB, Ethernet, and Bluetooth.Created and maintained traceability of test cases based on requirements.Experience creating test cases by using Selenium and Appium for Digital HealthWorked on injectors for sending contrast through an Angiograph via a catheter with disposable kits.Worked with US injector types and OUS (EU) injector types.Experience with injector types for the US and EU based on RFIDs.Reported Bugs in Jira and ensured the correctness of test results.Experience and supported the various teams throughout the FDA submission process.Experience in product development activities, including Requirements Management/Technical Risk Assessment/ FMEA/ Verification/ Equipment Validation of products(V&V).Supported risk assessment and system life cycle processes such as change control and document management.Supported continuous product and process improvement through detailed data mining, trending analysis, and failure investigations; developed and implemented effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and CAPA Programs.Responsible for ensuring that the medical devices software complies with existing regulations, applicable quality records, and SOPs, for reviewing reports regarding the tracking of the software projects and software issues, reviewing software requirements, verification, and validation plans/protocols/reports, which includes the software, for the final product in IEC PHONE NUMBER AVAILABLEAsensus Surgical Inc, Durham, NC Jan 2023 May 2023Software Quality EngineerProject: Laparoscopic Robotic SystemWorked on designing, developing, and executing the code, scripting, test cases and supporting the product requirements in SDLC projects and IEC PHONE NUMBER AVAILABLEImplemented software development life cycle (SDLC) activities in alignment with IEC 62304 and 82304 standards for medical device software, including Software as a Medical Device (SaMD).Participated in regulatory audits and inspections to maintain product quality, ensured compliance with regulatory requirements such as FDA, ISO 14971.Performed risk assessments, hazard analysis, and mitigate risks during the software development process as per ISO 14971 standards, focusing on potential software failures and their impact.Conducted regular risk reviews and maintain risk management documentation, integrating risk mitigation strategies throughout the New Product Development (NPD) lifecycle.Developed and executed validation and verification (V&V) protocols, test plans, and test reports to verify that software systems meet design and regulatory requirements.Supported quality assurance activities, reviewing test results, ensuring software design validations are aligned with risk management plans and standards.Collaborated with cross-functional teams to define and verify systems requirements, ensuring design requirements meet quality standards.Maintained documentation, including risk management reports, validation results, and quality assurance records, for regulatory audits and product approvals.Assisted with all aspects of Software and Product medical device life cycle process IEC PHONE NUMBER AVAILABLECreated new test cases, test runs, and ran the same on product.Prepared the documentation for tools, software and requirements following FDA norms and ISO 13485.Built IFS image files into the USB key and Configure BOIX for the QNX boxes.Created and maintained the scripts with Bash for automation test cases and deployed the build into FTP server within the QNX Box.Created and resolved bugs in Jira based on the test results and test reports.Experience in the Systems/regulatory requirements per FDA guidelines and ISO 13485.Generated Equipment Verification reports and exported into the documents and released the documents in Arena.Installed, configured, supported and tested operating systems, application software, and system management tools.Worked closely with developers on creating and debugging errors.Collaborated with cross-functional teams to design tools and manage systems that support business organizations and supported administration and implementation of tool solutions for software development lifecycle needs in medical device industry for class II devices following FDA regulations.Terumo Heart Inc, Ann Arbor, MI Nov 2019 Jan 2023Senior Software Quality Engineer and V & V EngineerProject: NxGen DUAL Sensor Imaging SystemDesigned, developed, and implemented SDLC capabilities for the Digital organization, including system configuration, administration, and custom scripts as needed and supporting business needs into product requirements to supporting the SDLC projects IEC 62304.Led the team for testing new and existing features on pre-release software and hardware to find problems before they impacted users. Developed and updated test coverage, created and maintained test cases, reported test results, and evaluated readiness to ship.Executed SW verification and integration process in compliance with SW standards IEC 62304.Reviewed and worked on documentation related to cybersecurity for product imaging systems.Developed plans, protocols, and reports to perform verification tests and mitigating defects and issues, Contributed to medical device SW life cycle process implementation per IEC PHONE NUMBER AVAILABLE standard.Set-up and maintained documentation, SOPs, Work Instructions (WIs), Records, and other related documentation in accordance with the Quality Management System.Designed the Europe language requirements and documented the Europe language implementation from console.Planned, implemented, and maintained the Quality Management System (QMS) in accordance with quality.Regulated compliance with review and maintenance of process related documentation, work instructions, records for relevance.Performed all activities in compliance with relevant GMP and QMS standards and specifically with FDA Quality System Regulation and ISO 13485.Performed quality reviews on end-to-end SDLC deliverables Data Migration Plans, Data Migration Test Cases, Qualification Test Plans, Test Scripts, Validation Summary Reports, 21 CFR Part 820 Assessments, Risk Assessments.Reviewed and approved equipment verification protocols and reports.Experience in developing and maintaining Risk Management Files including Risk Management Plan/Report, Hazard Analysis, design/process/use FMEA (Failure Mode Effect Analysis) per ISO 14971.Created and maintained the scripts with PowerShell / Python for automation, integration, and Python scripting with complex automated imaging systems & software.Experience setting up and using XY plotter, oscilloscopes, and pressure transducers for longitudinal image range.Used testing devices such as oscilloscopes to ensure proper equipment operation.Used Multimeter for checking the Angio signal with different volts.Supported developers, optical team and manufacturing team for the image calibration and product (Hardware) issues.Installed, configured, and tested Operating Systems, application software, and system management tools.Software Quality Engineer and V&V Engineer Jun 2017 Oct 2019Project: NxGen DUAL Sensor Imaging SystemDesigned, developed, and implemented SDLC capabilities for the Digital organization, including system configuration, administration, and custom scripts as needed and supporting business needs into product requirements to supporting the SDLC projects IEC 62304.Working experience in applicable standards and regulations, including 21 CFR Part 820, Part 11, ISO 13485, IEC PHONE NUMBER AVAILABLECreated and maintained the scripts with PowerShell / Python for automation, integration, and Python scripting and with complex automated imaging systems & software.Planned, implemented, and maintained the Quality Management System in accordance with quality systems/regulatory requirements in FDA guidances, ISO 13485.Implemented, maintained, and improved Quality Management Systems (QMS) and processes in accordance with the objectives of the organization.Involved in Functional Risk Assessment of the system along with client business, Validation & QA teams.Installed, configured, and tested Operating Systems, application software, and system management tools.Used WPF, C#, XAML technologies for GUI development and testing.Created and updated the C# and XAML in .Net frameworks.Collaborated with cross-functional teams including product development, production, quality, and customer support.Supported continuous product and process improvement through detailed data mining, trending analysis, and failure investigations, develop and implement effective and compliant solutions for product or process corrections, retrospective, and remediation action plans for CAPA Programs.Reviewed Corrective and Preventive Actions (CAPA) and suggested remediation plans to mitigate non- compliance.Developed and updated the test coverage, created and maintained test cases, reported test results, and evaluated readiness to ship.Used precision test equipment such as oscilloscopes, multimeters, waveform generators and spectrum analyzers to compile, process and analyze test data and results to improve product quality.Worked closing and supported the optical team and manufacturing team for the image calibration and product (Hardware) issues.Worked on class III devices following FDA guidelines.Education:Masters in Computer Science - Northwestern Polytechnic University, Fremont, CaliforniaBachelors in Computer Science and Engineering - Andhra University, Visakhapatnam, India |
