SUMEDHA ARORA
Glen Waverley,VIC
Summary
Analytical and process-oriented medical software V&V professional with 15+ years of professional experience in Fortune 500 organizations in various roles in Software verification and validation for large-scale, complex and digital products in medical imaging and surgical robotics portfolio.
- Delivered 30+ projects, 25+ based on Agile methodology
- Defining test strategy based on release strategy.
- Continuous integration, and Test governance plan in Agile environment
- Test Driven development, cross-functional collaboration, and iterative testing
- Test automation framework (In-house Hybrid scalable), processes and SOPs designing and review.
- Plan, strategize, coordinate, and execute System Testing, System Integration Testing, UAT activities with SMEs and stakeholders across globe
- Functional (Web based, API, UAT, Regression, Integration, Grey-box) and non-functional testing (stress, load, performance, security).
- Defect reporting, analysis, triaging and management using tools like JIRA, HP APLM, PTC Integrity, Jama, X-ray, Bugzilla.
- User Acceptance Test planning, scheduling, resource allocation, monitoring and reporting as per SOPs, Work Instructions, policies, processes, guidelines, and procedures.
- Excellent interpersonal skills, soft skills, and presentation skills (Impactful presentations).
- Paced up and adaptable to evolving technologies to suit business needs.
- Worked on numerous organizational initiatives like Application Lifecycle Management tool analysis and evaluation for Stryker-wide implementation.
- Worked on identification, application, and customization of JIRA for defect management and JAMA for Application lifecycle management.
- Rich experience in agile product development and forte in continuous improvement.
- Gathering requirements from marketing, Requirement and design documentation review, Review prototypes, Demo, Usability studies, requirement, and traceability management.
- Participation in Risk analysis, Failure Mode Effective Analysis meetings as a test functional leader lead by Quality Assurance team in adherence to ISO 14971.
Overview
16
16
years of professional experience
1
1
Certification
Work History
R&D Manager
Stryker
08.2022 - 07.2023
- Responsible for test planning, strategy and deliverables for UAT, System testing, System Integration testing, Regression testing and Gray box testing.
- Stakeholder management to ensure end-to-end UAT meets schedule and adheres to medical device standards
- BDD and TDD implementation.
- Developing team leaders by mentoring, coaching, and appropriate training
- Active participation in Risk management activities as per ISO 14971 and corporate Quality Management System.
- Implementing test automation using Squish for Qt/QML applications and enabling configuration management of test automation scripts by setting up the source code repository, versioning strategy, and continuous integration using Jenkins
- Designing the Work Instructions adhering to Quality Management System for Software UAT
- Process improvement following Kaizen and problem-solving techniques like 5y’s, fishbone analysis, making the test case creation, review, and execution process nearly 25% more efficient.
- Plugging JIRA with Jama
- Leveraged Jama APIs to integrate Jama with continuous integration tool Jenkins for auto execution of scheduled test cases, also auto-creation of test plan and test run in Jama, and auto recording of results back in Jama.
- POC, Computer System Validation and implementation of automated translation testing for seven languages reducing the testing cycle from 8 months to 3 months.
- Creation and presentation of test metric for requirement burndown, execution burndown, defect summary, defect density, and requirement burndown to the global teams. Defect Dashboards.
- · Building organizational capability for test automation and V&V project management.
- Partnered with sales, strategy and business development to identify new product opportunities, manage project portfolio and work assignments.
- Reviewed staff competencies to build employee skill sets based upon future technical requirements.
- Defined clear targets and objectives and communicated to other team members.
- Recruited, interviewed and hired employees and implemented mentoring program to promote positive feedback and engagement.
- Successfully managed budgets and allocated resources to maximize productivity and profitability.
- Reduced waste and pursued revenue development strategies to keep department aligned with sales and profit targets.
Associate Manager
Stryker
03.2019 - 07.2022
- Set and enforced performance and service standards to keep consistent, high-quality environment devoted to customer satisfaction
- Remedied issues and conflicts among workers using negotiation and active listening
- Coordinated resources from stakeholders and mapped out project deliverables
- Mentored team members to enhance professional development and accountability in workplace
- Tested, identified and troubleshot problems with networks
- Tracked test reports and failures determined by root cause data trends
- Reviewed, evaluated, and identified requirements for testability
- Developed and maintained test and evaluation strategies for testing to show operational readiness and suitability with planned project decision points
- Created comprehensive test plans, test scripts, and use cases to support testing objectives
- Developed comprehensive test plans and workforce breakdown structures for complete systems
- Created plans for test method validation using research or field observations
- Provided solutions to various technical problems of varying scope and complexity
- Secured and allocated resources to manage planning and operations in testing cycle
- Operated under Agile and Scrum frameworks to complete releases and well-organized sprints
- Recommended changes and corrections to developers for optimal software performance and usability
Associate Tech Lead
Stryker
03.2018 - 02.2019
- Managed team performance by training, mentoring, disciplining, and motivating employees
- Planned, scheduled, and delegated daily work to team of employees
- Managed daily activities, assigned tasks to specific staff members and utilized proven management techniques to cut work flow downtime and maximize revenues
- Adhered to established policies and standards to safely complete projects
- Validated adherence to best practices, quality standards and customer specifications
- Fostered relationships with internal and external customers
- Tested components and systems to evaluate performance and identify concerns
- Drafted system setup and imaging documentation, creating standardized frameworks to rapidly onboard new hardware
- Leveraged Lean Six Sigma expertise to reduce waste and enhance productivity
Staff Engineer
Stryker
03.2017 - 02.2018
- Provided input to team lead regarding areas for process and procedural improvement
- Evaluated data sets from multiple test implementations to determine and account for standard variance in test results
- Reviewed all test cases and test scripts for quality and identified additional areas to review
- Documented current production methods to identify points of limitation to target for quantification through testing procedures
- Fixed identified issues to improve workflows
- Optimized test cases to maximize success of manual software testing
- Tailored testing procedures to obtain data most relevant to understanding underlying causes of production limitations
- Identified bugs and issues within system and applied troubleshooting techniques for mitigation purposes
- Assessed software bugs and compiled findings along with suggested resolutions for development team members
- Collaborated with product owners to stay current on intended functionality
- Outlined concrete methods of utilizing calipers and tape measures to gather measurements of production units
- Determined server operating limits with weekly load tests
Sr. Software Engineer
Stryker
04.2016 - 02.2017
- Worked with project managers, developers, quality assurance and customers to resolve technical issues
- Worked with development teams to correct problems and run test scenarios
- Promoted technical leadership to entry-level and junior engineers in complex enterprise system environment
- Led software development initiative as subject matter expert and primary point-of-contact for project management staff
- Provided technical support using knowledge of complex technology to solve problems and support new projects
- Checked client code for bugs and weaknesses using approved troubleshooting methods
- Practiced and encouraged respectful and transparent communication in interactions
- Worked with software development and testing team members to design and develop robust solutions to meet client requirements for functionality, scalability, and performance
- Collaborated with clients to define solution requirements
- Integrated third-party tools and components into applications
- Optimized test cases to maximize success of manual software testing
- Worked closely with different departments to develop innovative solutions to functionality issues
- Assessed software bugs and compiled findings along with suggested resolutions for development team members
- Created successful test scripts to manage automated feature testing,
Software Verification Test Leader
Danaher
04.2012 - 04.2016
- Created testing scenarios for long-term and expedited development schedules
- Reported test findings to development personnel, advising staff on efficacy of subsequent remediation attempts
- Maintained authoritative knowledge of multiple software testing tools
- Reviewed, calibrated and validated equipment used in manufacturing of Dental Imaging products
- Remained compliant with federal, state and municipal regulations related to safety of company and personnel
- Tested functional and compatibility of new programs or updates in comparison to existing applications
- Documented testing procedures for developers and future testing use
- Authored and maintained well-organized, efficient and successful manual test cases for entire team
Software Verification Engineer
Danaher
11.2007 - 03.2012
- Optimized test cases to maximize success of manual software testing
- Identified bugs and issues within system and applied troubleshooting techniques for mitigation purposes
- Planned and devised cohesive test plans for projects using advanced testing technologies
- Met with quality assurance, developers and project managers to assess scope and sequence of project
- Implemented user acceptance testing with focus on documenting defects, identifying bottlenecks and executing test cases
- Monitored resolution of bugs, tested fixes and helped developers tackle ongoing problems by providing QA perspective
- Operated under Agile and Scrum frameworks to complete releases and well-organized sprints
- Incorporated delivery requirements into planning of testing schedules
Education
Bachelor - Engineering in Biomedical Engineering
Maharishi Dayanand University
India06.2007
Skills
- Test Management Tools
- Test Driven Development
- Agile Product Development
- Release and Test strategy
- User Acceptance testing
- Integration Testing
- Black-box testing
- Risk Management
- Requirement Gathering and management
- Project Management
- People Leadership - Situaltional Leadership
- Defect Dashboards
- Regulatory Standards
- Organizational Skills
- Requirement Analysis
- Design Quality Management System
- Software Development Life Cycle
- Software Testing Life Cycle, Agile
- Scaled Agile
- ISO 9001:13485
- ISO 14971, IEC 62304, IEC 60601, FDA 21 CFR Part 11
- Goods Manufacturing practice
- Rest API
- Cucumber studio
- Atlassian JIRA and confluence
- Sharepoint
- Squish with Python and javascript for Qt/QML, NET and web based applications
- Jama
- PTC Integrity
- Azure DevOps
- DevOps – CI/CD, Gitlab, perforce, Jenkins, Docker
- Minitab
- Citrix desktop virtualization, VM Ware
- Kanban
- Kaizen and Six Sigma – Analysis Tools
- Stakeholder Engagement
- Enterprise Architect
- Defect creation and management,
- API testing
- Use case analysis
- DICOM/PACS, HL7, HRIS
- Patient Data Management Systems
- Interpersonal Skills & Effective communication
- Impactful presentation
Certification
- ISTQB (2008) Radiation Safety Officer (2013) by Bhabha Atomic Research Center, India
- Project Management Professional (2017)
- Scaled Agile Framework – SAFe (2018)
- Kaizen (2009)
- ISO 9001:13485 Internal Auditor
Affiliations
- ISTQB (2008)
- Project Management Professional (2017)
- Scaled Agile Framework – SAFe (2018)
- Kaizen (2009)
- ISO 9001:13485 Internal auditor
- ISO 14971, IEC 62304, FDA 21 CFR 11
- Squish for Qt/QML applications
- Microsoft Project
- Python, javascript and VB script
- Society of Women Engineers
- Impactful Presentation.
- LEAD-100 & LEAD-200 (Stryker’s leadership development program)
- Behavioural Interview practices.
- Working in Matrix organizations
- Radiation Safety Officer (2013) by Bhabha Atomic Research Center, India
- Completed in-house training on “Project management in the healthcare industry”, “Lean Six Sigma Green Belt”, “Agile methodology”, “Stakeholder Management”, “New Product Development”, “Software as Medical Device Data Systems,”
- “Unconscious Bias,” “Presentation advantage,” “Working in a matrix organization” and “cross-cultural work model.”
- Radiation Safety Officer (2013) by Bhabha Atomic Research Center, India
Timeline
R&D Manager
Stryker
08.2022 - 07.2023
Associate Manager
Stryker
03.2019 - 07.2022
Associate Tech Lead
Stryker
03.2018 - 02.2019
Staff Engineer
Stryker
03.2017 - 02.2018
Sr. Software Engineer
Stryker
04.2016 - 02.2017
Software Verification Test Leader
Danaher
04.2012 - 04.2016
Software Verification Engineer
Danaher
11.2007 - 03.2012
Bachelor - Engineering in Biomedical Engineering
Maharishi Dayanand University