Engineer Medical Device

SHILPA BASAVARAJ

San Jose CA – 610-***-**** - **************@*****.***

USA work Authorization - Green Card holder

Test Lead

A performance-oriented software Test lead with proven team management skills and diverse technical experience that derives strategies & execution for solving problems at scale. Strengths include leading and developing effective testing teams, resolving conflict, communicating technical solutions to customers and leveraging internal cross-functional relationships, Integration & Release and system verification for advanced next generation healthcare software industry.

Skills:

• C • Python • Rest API Testing

• Selenium • GIT • TFS

• Windows • Quality Center, ClearQuest • Jira

• Effective Leadership and Team • Excellent communication skills • Customer Orientation

Management Skills • Highly Detail Oriented • Cross Functional Team Leadership

Technical & Management Proficiencies:

Agile Scrum and Waterfall Methodologies

Medical Device system integration and Production

Team Management

Understanding of auditing to standards or regulations such as ISO 9001, ISO 13485, ISO 14971, IEC 62304, the FDA Quality System Regulation, Medical Device Directive and/or Canadian Medical Device Regulation.

Product Quality Management and Process, Product requirements to Verification plan and strategy, Test Design, Test setups, Automation, software verification and validation.

Hands on experience in automation with Python and Selenium Web driver and Rest API with pytest.

PROFESSIONAL EXPERIENCE

Varian Medical Systems, Palo Alto, CA

Software Quality Assurance Engineer July 2018 Present

SQA Lead - Imaging & DICOM applications, Treatment Delivery, Plan and Care applications integrated with Oncology Information system.

Coordinate test strategy development, project planning, scheduling, allocation of test engineers, ensuring test environment availability, generation of test reports, communication of test status, and networking to coordinate test activities.

Work and collaborate with cross functional groups within product development to ensure alignment of project priorities and timelines

Participate in review and approval of product deliverables (e.g. project plan, risk assessment, design documents, FMEA, DRR, CAPA)

Drive and hands on Rest API testing using pytest.

Manage and maintain simulated environments and clinical equivalent test environment.

Participate in internal and external audits before regulatory authorities.

Responsible for setting up an Accountable Individual & Team Goals, Performance Evaluations, Coaching, Empathy Management.

Siemens Technology and services, Bangalore, India

Consultant July 2010 Oct 2014

Successfully lead test team of 4 engineer’s responsible for systems integration testing of Radiotherapy solution provided by Siemens for cancer treatment.

Served as Customer Offshore integration lead and system integration test activities, set up Labs at offshore and handled integration issues and bug triage.

Collaboration with the customer involving schedule alignment of project priorities and timelines

Designed and developed Build Acceptance Test Strategy and supported continue integration based on Agile schedule with offshore development team.

Greatly improved integration of test engineers with development teams resulting in a cohesive work environment

IGATE Global Solutions, Bangalore, India

Senior system Analyst Dec 2009 to June 2010

Test engineer responsible for UI testing for Banking application on mobile devices.

Aricent Communications, Monterrey, Mexico

Senior Test Engineer June 2008 to Nov 2008

Perform protocol conformance testing of Layer 2 and Layer 3 signaling of air interface of 2G/2.5G/2.75G mobile handsets.

Siemens Information Systems Ltd, Bangalore, India

Associate Consultant June 2004 to Sept 2007

Lead verification engineers for Siemens Healthcare information systems – Soarian and Siemens departmental solution like operation room management system and oncology solution systems.

Developed test plans, test cases, test data, test summary reports, resolved testing issues, represented the team at project meetings and prepared the weekly status reports

Managed test execution and defects reporting

Preparation of Integration Test Procedure and incorporating internal/external review comments

Perform require based functionality, workflow, exploratory and localization testing

Generation of Traceability matrix and test coverage.

Mentoring and coaching team members

HP Global Soft Ltd, Bangalore India

Test Engineer June 2001 to June 2004

Applications repackaging to Microsoft msi standard. Testing for proper Installation on target platforms. Functionality Testing of the Application. Quality Checking (QC) and Application deployment using SMS 2.0

EDUCATION

Bachelor of Engineering in Computer Science,

S.D.M College of Engg & Tech, Karnataka University Dharwad, Karnataka, India

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