SUMMARY:

• A self - driven Biomedical Engineer with over 7+ years of extensive experience in Medical Devices, R&D, Project Management and Quality Assurance.
• Expert skills in all phases of Software Development Life Cycle (SDLC) and adept in implementation and maintenance of Quality Engineering Processes.
• Well experienced in On-shore off-shore coordination, Team Leadership, Project management, Coordination, Requirement Gathering analysis by conducting JAD (joint Application Development) sessions with SME’s of the projects.
• Extensive experience in Test Planning & Strategy, Test Designing and scheduling, Test Cases, Defect (CAPA & EPR’s) Logging, Test Environment Setup, Feature Testing Software Installation, Test implementation and Software Documentation reports and working with Requirements Traceability Matrix (RTM).
• Thorough knowledge of performing manual software testing including Integration testing, unit testing, regression testing, user acceptance testing, Smoke Testing, functionality testing (Black box) and customer run testing.
• Proficient in manual testing tools such as MTM (Microsoft Test Manager), TFS, QualityCenter and WinRunner.
• Deep knowledge of working and executing projects risk free and with high quality under FDA and ISO regulations via utilization of risk management techniques such as FMEA, ALARP etc.
• Ability to understand and improve system quality by evaluation, to ensure compliance to cGMP, GLP industry standards and regulations such as ICH, GCP, FDA, MDD, ISO 13485, ISO 13485, ISO 14971, ISO 14155 and other regulatory authorities.
• Experience of managing a complete laboratory including maintaining the tracks and analyzers, meeting the Quality and compliance standards via going through internal QA and external LRQA, FDA audits.
• Ordering and purchasing, budgeting of resources, Electrical parts, reagents and consumables via SIEMENS ONE SRM (SAP) shopping tool.
• Capability to provide scientific/ statistical input during the development and execution of plans and during testing.
• Demonstrates the ability to work in team settings as well as lead, organize, prioritize and assist with multiple projects.

TECHNICAL SKILLS:

Tools: Microsoft Test Manager, Team Foundation Server, DevTrack, Visual studio test professional 2015, MS Word, MS PowerPoint, MS Access, Outlook, EMPOWER

Databases: Microsoft Access, MS-SQL Server.

Operating Systems: MS DOS, Unix, Windows NT/9x/2000/XP/2009, SQL Server

Design/Process: Agile, UML, RUP, WaterfallTesting tools: JIRA & Dev Track (defect tracking), HP quality center, TFS, MTM, Quality Center, TCRE.

Languages: SQL, HTML, C, C++, MATLAB, LabVIEW, JAVA.

Electrical skills: Signal processing, image processing, embedded systems, MEMS, RF.

Electronic Tools: Oscilloscopes, power supplies, functional generators, multimeters, calibrations.

PROFESSIONAL EXPERIENCE:

Confidential, Tarrytown, NY

Software Test Engineer / QA Lead

Responsibilities:

• Involved in defining test objectives for the images for Manual Testing approach.
• Involved in team meetings and JAD Sessions with SME’s, Managers and Developers in identifying Scope of the existing project.
• Involved in giving inputs for requirement writing and Design verification Plan to be added to DHF (Design History File) within SAP.
• Involved in Risk Management designing including techniques such as FMEA and ALARP
• Getting sign-off’s from Design Qulity Engineers for documenting plans in SAP.
• Involved in writing tool validation plan for the current OS version.
• Writing test cases for OS images: Build 1 for 14 instrument interface PC’s for future execution.

Confidential, Tarrytown, NY

• Involved in team meetings and JAD Sessions with managers and rest of the team in identifying Scope
• Involved in gathering requirements and collecting information regarding project plan, timeline, resources, team management and sprint planning using an Agile approach
• Responsible for analyzing and reviewing verification and validation deliverables such as user requirements, verification plan, functional requirement specification, system design specification document.
• Developed test plans and scripts for LAS (Lab Automation software) version V4.12.1 Implemented software verification and validation procedures related to software version changes and obsolescence, process improvement and new features.
• Reviewed acceptance criteria with the software team and development lead.
• Attended project sprint planning meetings.
• Design, develop and construct test plans/procedures in MTM (Microsoft Test Manager) used to evaluate medical diagnostic devices, including software, hardware and system interaction for new version V4.12.1 keeping in mind the acceptance criteria for each test requirement.
• Planning, conducting and evaluating results for software testing associated with the project.
• Preparation of reports on findings and makes project recommendations based on results of testing.
• Participated in Design review process and commercialization.
• Maintain Requirement Traceability Matrix (RTM) and test cases both planned and executed for all software releases.
• Garnered system/Operator level expertise on the instrumentation, Assay, Maintenance, software and GLP’s in lab.
• Practice company safety and quality policies and procedures to ensure personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental. A major participant of External LRQA/FDA Audits.
• Work with extended cross functional teams to ensure adequate test coverage Troubleshoot product defects to drive to root cause.
• Provide technical assistances for hardware and software debugging.
• Maintaining log books for all instrument related issues, Perform as needed maintenance as described in the maintenance procedure for each issue. Open EPR’s and CAPA’s in case of hardware issues.
• Maintaining a safe environment in the lab by managing, organizing and maintaining inventory. Placing orders for consumables related to each individual instrument as per requirement via Siemens Internal Ordering system - One SRM.

Confidential (Flanders, NJ)

• Execute developed test cases/procedures in MTM (Microsoft Test Manager) to conduct verification testing for the VersaCell software version V4.4.
• Executed test cases to fix previous development related software issues (SCR’s) fro build 2 and build 3 for SWV 4.3
• Performed Regression testing to ensure that existing features are not affected by the changes in Software Version V4.4
• Verified Work orders were successfully created and downloaded from the LIS simulator V2.2.0 to the VersaCell.

R&D Engineer/Project Manager

Responsibilities:

• Project Lead, managing a 4.1M $ grant for sequencing influenza A & B vaccine virus candidates and to study the mutation pattern pertaining to the higher growth of the re-assortants in eggs for production of influenza vaccines utilizing the funded Waters Corp. Ultra- purified liquid chromatography (UPLC) (Waters Acquity H-class).
• Involved in analyzed numerous influenza A & B wildtypes strains to quantitate their virus yield via advanced lab techniques and automated software tools such as Empower.
• Defined clear Scope for the project for specific requirements gathered via clients and stakeholders during JAD sessions.
• Defined the project scheduling, budgeting, and allocation of resources, trainings, development and testing (QA) to ensure perfect release of deliverables on time.
• Ensured implementation and maintenance of the effectiveness of the Quality system to meet regulatory requirements, FDA cGMP/GLP, SOP and OSHA, ISO 13485.
• Researched and optimized standard operating procedures for sample preparation, buffer preparation, consumables ingredients etc and tested them for productivity and improved Quality.
• Executed Installation, troubleshooting (Assay Calibration failures, failures testing) and performed Maintained Laboratory, Execution of models, designed Experiments, Ordering, Waste disposal (EHS), Lab personnel training etc.
• Involved in data acquisition, integration, analysis and final quantitation all in compliance to cGMP/GLP and SOP guidelines.
• Supervised the Corrective Action system: Review for submittal, assistance in root cause definition, monitoring status, escalating issue, CAPA closures and system reports to management.
• Planned, deployed and lead all lean activities that produced significant cost savings though productivity, quality, waste reduction improvements, and improved business process.
• Assist in maintaining Design history file (DHF), Device master record and design history recorded.
• Implemented periodic preventive maintenance on the UPLC and all other laboratory automated equipment such as centrifuge machines, automated analyzers, scopes and imaging equipment.
• Implemented periodic verification and validation testing of standard curves for accurately computing the yield of flu strain and fold increase to corresponding wild-types via UPLC quantitation. Created Test Plan, test cases for software testing using MTM/TFS to ensure correct work.
• Conducted User Acceptance Testing (UAT) for influenza A & B vaccine candidates.
• Developed traceability matrix.
• Designed and developed new functional assays, innovated the existing ones to optimize the production in the right path. Utilized common lab techniques such as protein expression and purification and recovery by Western and SDS-PAGE, PCR, QPCR and real-time RT-PCR.
• Document work according to cGMP standards. Perform inspection on equipment and manage Quality and technical agreements to ensure revision before expiration. Assist in internal and FDA audits and determine and implement proper corrections for the audit findings.
• Supported existing lab automated equipment providing software & hardware troubleshooting.

Research Assistant

Responsibilities:

• Lead a team of interns to conduct research on designing bio-sensors and point- of care signaling devices for early detection of beta-thallasemia disorder.
• Investigated the study of specific substrate and transducer materials in compliance to industry standards, for transduction of protein interactions into bio-potentials.
• Reviewed current & future trends in sensor material & system integration technology and ways to use this technology to achieve enterprise goals.
• Researched the complete internal chemistry related to antigen and antibody selection and they dynamics of binding to produce the desired signal.

Biomedical instrumentation-Research Assistant

Responsibilities:

• Developed algorithms in Labview to acquire, control and monitor real-time ECG signal via a circuit designed over a Printed circuit board.
• Implemented filters and signal processing tools in MATLAB to produce noise free signals for quality assurance.

R & D Test Engineer

Responsibilities:

• Part of a team project to research & develop a cost effective and compact medical device that efficiently acquires signals from patient’s body to evaluate blood volume measurements and autonomic nervous system parameters.
• Acquired noise free signals via incorporating Electrical assembly comprised of a single LED IR sensor worn over index finger making device non -invasive. Programed device electronics, built and evaluated prototype design, test and analyze device via MATLAB application.
• Developed small scaled models based on Mfg. unit operations to troubleshoot problems and defects.
• Prepared project charter via conducting JAD sessions with stakeholders to gather requirements.
• Designed test cases for Functionality, Validation and Regression Testing for application.
• Developed a functional test matrix considering all aspects of the application.
• Developed and reviewed test automation scripts using WinRunner for regression testing of the various releases of the device.
• Responsible for making the detailed QA test plan and risk assessment plans regarding the scope and focus of the testing
• Developed Ergonomic test cases, to evaluate the equipment within biomechanical parameters/Human Factor Engineering to ensure the human body would interact with the equipment appropriately.
• Designing programs and criteria establishment for conducting bio mechanical testing on subjects to evaluate proper parameter functionality.
• Designed and developed cost efficient Automatic Medication Dispenser, The design worked on a real time PCB system, triggering an alarm at a preferred time to dispense the amount of medication (Awarded at IIT Tech Fest, Bombay’09 for best Innovative Idea) Ideally for old and paralyzed people.
• Investigated device safety related incidents and safety protocols by keeping up to date with new developments in the healthcare field.
• Designed device training and quality control (QC/QA) protocols/manuals for technical and clinical staff.
• Worked closely with the development team to develop and implement testing plans.

Field- service Engineer/ QA

Responsibilities:

• Key player on field engineering team, providing installation, application and quality control on Somatom range of Diagnostic imaging equipment such as CT and MRI.
• Assisted, on demand preventive maintenance protocols, executed assembly related troubleshooting on for all imaging modalities to clients across New Delhi city.
• Analyzed business requirements, functional specifications and mock ups of financial to provide functional decomposition. Gathered experience of working on company DCS (Distribution control system).
• Conducted installation and cross-platform testing of Internet Configuration Wizard application (Visual Basic 6.0, various Windows platforms)