Arpita Singh Kushwah

• Dedicated and meticulous Medical Device (Product) Tester with over 8+ years of hands-on experience in System Level Testing, Medical device (Product)functional testing, Verification & Validation.
• An expert in Requirement elicitation, skilled in gathering and documenting requirements by understanding the Business logic and industry standards
• Experience on Integration testing at system level.
• Having a knowledge on medical standards ISO13485, ISO14971, IEC 62304.
• Knowledge on Risk analysis process like FMEA & DFMEA.
• Experience in preparation of other artifacts such as Traceability Matrix Document, checklist, KT document & prepare the release document as per the compliance.
• Prepare the business documents like Daily Status Report, Weekly Status Report and MOM etc.
• Experience in CSV and GXP including HLRA, IQ, OQ, PQ.
• Experience to manage internal and external audits.
• Knowledge on automation testing using selenium and API testing using Postman.

Certified [Scrum Master] [Scrum Alliance] - [14 May 2023]

Motivated and seasoned Medical Device Tester with a track record of 8+ years in the field. Seeking a dynamic role to apply my in-depth knowledge of medical device testing, encompassing regulatory adherence, quality control, and effective collaboration with diverse teams. Eager to contribute my analytical skills, attention to detail, and proficiency in testing methodologies to enhance product quality and compliance within a forward-thinking organization.

SVN, Postman, JIRA, Farser, Windchill, Polarion,  Artifactory, Bugzilla, Rufus.

Project 1: SN Cori Console (Medical Domain)

Role: Product Test Engineer

Team Size: 12

Duration: 2.7 Yrs

Project Description: The CORI Surgical System provides portable, handheld robotics with the smallest footprint in knee arthroplasty. The technology is designed to help surgeons achieve more accuracy in bone resection and alignment through intraoperative planning, smart mapping and full range-of-motion data collection, for reduced wear and higher implant survivorship.

Responsibility:

• Having an experience on writing verification protocols at system level Involved in peer review, QA review and Client review discussions.
• Drafted the test protocols using the Windchill tool.
• Download the build from Artifactory.
• Burn the build using Rufus.
• I am responsible for retesting and updating the status of Jira tickets for fixed defects.
• Conduct root cause analysis for identified defects and work towards effective resolutions.
• Monitor and analyze test results, providing clear and concise reports to project stakeholders.
• Conduct exploratory testing to identify potential issues based on product Knowledge.
• Perform system integration testing to ensure the seamless interaction of different components.
• Provide mentorship and guidance to junior test engineers.
• Coordinate with project managers to ensure testing activities align with project timelines.

Project 2 : Clinilan and Transportation system Modules (Medical Domain)

Role: System Team Lead

Team Size: 4

Duration: 9 Months

Project Description: As an Integrated Solution Provider A&T works on product development, manufacturing, marketing

and customer support in the all fields of C・A・C・L(Chemicals, Analyzer, Computers, Lab-Logistics).

Responsibility:

• Expertise in crafting system-level requirements by comprehending the functionalities of devices.
• Involve in weekly and daily status given system level understanding to cross functional teams.
• Handling the team of 4 people and working as System Team lead.
• Involve in query resolution meeting with client.
• Having an experience on writing verification protocols at system level Involved in peer review, QA review and Client review discussions.
• Experience on planning and Documentation.
• Attending the training sessions and behalf of offshore team discussing about all points with clients in meeting.
• Go through the regulation documents and standards which device must follow.
• Performed devices lab set up using the standard IOC 17025.

Project 3 : CODAN Argus Volumetric Infusion/Syringe Pump  (Medical Domain)

Role: Senior Test Engineer

Duration : 6 Months 

Team size : 6

Project  Description : Introducing the next generation of innovative Barcode
Assisted Infusion.With this generation of BAI, CODAN ARGUS presents a unique
and innovative solution that increases both patient safety and
workflow efficiency in hospital environments where time and
precise application of drugs play a critical role.

Responsibility : 

• Understood System and Sub System level requirement documents.
• Responsible for writing the test protocols at System and Subsystem level.
• Involved in Peer Review and team review of test protocol documents.
• Performed Dry run and Formal testing, raised the defects in JIRA.
• Draft the test cases in Polarion tool.
• Performed HL7 data verification using Farser tool.
• Effectively handling a team of four freshers and providing them with comprehensive knowledge of products and Software Testing Life Cycle (STLC) requires a combination of leadership, communication, and mentoring skills.

Project 4: Partner Tool (Medical Domain)

Role: Tech Lead 

Team Size: 5

Duration: 1 yrs

Project Description: Partner tool application is developed in order to control and monitor the services. Communication occurs with all the medical devices connected in Network along with Therapy manager. Request and responses are observed on the partner tool application. This simulation tool is basically used for the maintenance & debugging purpose.

Responsibility:

• Understood Software and System requirement specification.
• Set up and executed tests using MQTT for request and response messages and manual methods as applicable aligning to overall test strategy defined
• Raised defects, provided sufficient details and logs for further analysis and worked with client development and testing team , closed the defects with appropriate root cause analysis documented.
• Experience of working in Life Science (Healthcare) Domain in waterfall environment.
• Designed test cases as per new requirements.

Project 5: Therapy Manager (Medical Domain)

Role: Senior Test Analyst

Team Size: 4

Duration: 1 yrs

Project Description: Therapy Manager is a medical device, which monitors and controls all the therapies from central location, which consist of Com-box, ONG Pump, Rack arrangements, channel relay, and it’s connected to patient. In a broader perspective, PDMS is taken care by TM.

Responsibility:

• Functional testing, Bug verification, regression testing, Sanity testing, Smoke testing
• Experience of working in Life Science (Healthcare) Domain in waterfall environment
• Designed test cases as per new requirements
• Raise the Defects and logging the defects in JIRA
• Updating Test Cases, Test Data and deliver checklist after fix all the criteria.
• Tracking Changes through SVN, preparing weekly Reports and Updating Documents.
• Giving KT to newly joined team members.

Project 6 : ONG Volumetric Infusion Pump/Syringe Pump  (Medical Domain)

Role: Test Analyst

Duration : 2.6yrs 

Team size : 6

Project  Description :Infusion pump delivers nutrients or drugs to the patient with defined rate and defined volume for definite period. The pump is intended to deliver the drugs from a very small volume to very large volume as a result accuracy is maintained. Feature enhancement and HMI level testing is mainly in scope.

Responsibility : 

• Understood System requirement specifications & updated test cases if requirements gets changed.
• Responsible for testing of HMI screens workflow / alarms /contents /Pump configuration/ ML-H Programmatic, startup, dose rate, General Menu modules.
• Functional testing, Bug re-verification, regression testing, Ad-hoc testing.
• Created complete HMI workflow for VP & wrote PV’s for SP.
• Upgrading software and flashing of the devices with the help of “Heroine tool.
• Responsible for Test Scenarios, Documenting the Test Cases and Collecting Test Data for Functional Testing.
• Updating Traceability Matrix Document & prepare the release document as per the CE & other regulatory and quality compliance.
• Did Sanity Testing, Regression Testing on modified new Software Builds.
• Collecting Test Metrics and Documentation. Maintained Query Tracking sheet & raised

to customer.

I hereby declare that all the information provided by me is factual and correct to the best of my knowledge and belief.