Software Testing | Verification & Validation | Medical Device Software R&D| Mobile/web app testing | FDA and ISO regulated environment | CSM Certified | freelancer | Web design/devlopment
- 10+ years of Software Testing experience delivering high quality medical products, mobile and web applications.
- Strong working knowledge in quality software engineering processes in compliance with ISO, FDA standards including 510(k) clearance.
Project : FDA program - 510k Submission/Clearance for US market launch of the Abbott Alinity h-series
Description: As an integral member of Abbott Hematology’s Software Engineering R & D team, my role involved supporting the software verification process of medical device software. Also, support development software releases by performing acceptance testing, logging defects, and providing recommendations on build readiness. Working in the lab on medical devices with robotics technology, barcode reader, real specimen samples as well as simulators to test actual instrumentation for software defects. This role can highly impact identification and treatment for hematology patients by implementing products in hospitals and laboratories.
Responsibilities:
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Work with the requirements team to understand business needs - Familiar with ALM tools - Doors, Helix, Rational
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Work with test leads and software developers to ensure quality processes are integrated throughout an iterative and fast-paced development agile environment.
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Write test protocols from technical designs, specifications, and requirements. Review/approve teams test protocols. Familiar with tools like HP Quality Center
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Dry run, approve & execute software verification test protocols for manual and automated test cases. Create detailed and optimized test designs for software features and functions. Review and approve team's formal test runs.
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Perform smoke, integration, acceptance, regression and stress tests on the software releases, perform NPV-non product verification for simulators used for testing. Configure basic switches and routers connections as part of testing, analyze system logs and reports as part of debugging. Familiar with working in QNX and Linux environments.
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Maintain traceability of requirements to protocols.
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Isolate, characterize & log new software defects with detailed defect reports.Verify & close resolved software defects. Familiar with Jira, SBM defect tracking tools
Build, manage, mentor and inspire a high performance Quality Engineering team
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Execute test plans and create test reports to describe program evaluation, testing, and correction
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Worked towards introducing automated CI/CD process into the system using Jenkins
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Assist Application Developers and technical support staff in identifying and resolving problems
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Recommend design improvements or corrections to engineers throughout the development process
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Work closely with the development team and come up with unit tests after each commit
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Deliver quality assured user stories/bugs on time at the end of every sprint
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Brainstorm with the product owner and come up with a detailed use cases for the user stories. Provide product information as a quality person while designing user stories
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Write technical documents for the marketing team for their client presentations and for the website
