
Avinash Kumar Tiwari
Sr. System Engineer

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About me
SAFe®5 | PSPO® | ICP-ACC | MS Azure | Agile | SaMD | Medical Algos | Oncology | Medical Device Testing | Product Risk Management | Scrum | Product V&V | Product Compliance | Ex-Elxsi | Ex-Varian | Ex-Siemens |
Education

Manipal Academy of Higher Education
-Master in Information Technology IT
Sikkim Manipal University - Distance Education
-Master of Business Administration (M.B.A.) Project Management.webp)
Centre for Development of Advanced Computing (C-DAC)
2005 - 2006Diploma in Advance Computing Information Technology B+
Experience

Siemens Healthineers
Aug 2007 - May 2009Sr. System Engineer• Authored testing procedures and PLC documentation and executed during formal verification.• Configured Test Environment with system release build to head BAT, System Testing, Manual Testing and Regression Testing.• Participated in multiple reviews like Requirement, PLC artifacts, Test Case, Defect with respective stake holders to facilitate measurable quality.• Done Device Testing on real Ultrasound devices, Hardware and Firmware Testing along with different software methodologies and MTBF. Show less

Varian Medical Systems India Software Pvt. Ltd
Jun 2009 - Jul 2020* Acted as liaison between business, users, sales, IT and Global teams to refine the product and incorporate features based on market demands.* Created and maintained the product vision, product roadmap, and product backlog throughout the project's life cycle in Sprints.* Translated features into user stories (more than 350+ for both Projects) within the team’s product backlog while managing, refining, and prioritizing this product backlog to reflect stakeholder’s requirements.* Planned and estimated 2-week sprints in a time-efficient manner that allowed the teams to deliver 97% of the MVP as per company roadmap.* Participate & lead meetings with team for Backlog Refinement, Sprint Planning, Sprint Reviews and Sprint Retrospective.* Performed User Acceptance Testing after reviewing test cases to confirm of the deliverables address the customer pain points.* Provided Product Demos to Beta Customers to gather feedback before Go Live. Collaborated with Tech writing team for user manual and release note.* Ensured the User stories meet the team’s Definition of Done following Scrum - Agile Methodology.* Effectively negotiated sprint goals with the team, which resulted in slashing delivery time by 20% in 2 quarters. Created Go To Market plan. Show less • Coordinated with the multi-disciplinary cross functional team (R&D, Dev, PMO, PDM, Testing, 3rd party for Mobile App currently)• Developed team communications and information for scrum meetings and followed Agile in project by acting as Scrum Master for Mobile app project.• Resolved peers problems during testing by mentoring and contributing, improved product quality by reporting quality defects and provided exceptional product quality support.• Handled Azure Infrastructure and deployment for Mobile App and Facilitated team in Mobile App Testing on Android and IOS devices (mobiles and tablets).• Participated in FDA audits and RCA for NC & CAPA.• Handled customer complaints by leading the complaint team to ensure quality product and customer satisfaction. Also headed Tool Validation for third party tools and licensed tools used within Company.• Participated in Design FMEA (DFMEA) and Failure mode Effect Analysis (FMEA) as per ISO-13485• Authored & maintained Test Procedure in QC as well as coordinated DR management.• Configured Test Environment with system release build to head BAT and Functional Testing.• Chaired with Product Owner in PRD review to understand needs and headed proven S/W quality• Participated in multiple reviews like Requirement, PLC artifacts, Test Case, Defect with respective stake holders to facilitate measurable quality.• Facilitated and coordinated team communication over project meetings, reviews, demo and retrospect as per PLC guideline.• Instrumental in ETL testing for Report Analytics in Agile ecosystem.• Facilitated proven customer satisfaction by reporting quality defects before production.• Participated in DFMEA, FMEA and RCA for NC & CAPA. Show less
Validation Lead
Jan 2016 - Jul 2020Sr. QA Engineer - L III
Jun 2009 - Dec 2015

Tata Elxsi
Dec 2020 - Oct 2022Senior Specialist* Chaired multiple QA projects simultaneously with a focus and delivering highest quality product by following Best Practices in Software, Firmware and Hardware Testing as well as making sure customer demands and quality are respected.* Managed and coordinated team of 12 resources in successful implementation of QA Road Map with Customer Project Rating from 4.2 to 4.9. * Implemented QMS – ISO 13485, ISO 14971, Risk Based Test Approach and reduced Test Time along with Production Defect by 30% by implementing improved regression testing methods as well as stringent multiple review process.* Chaired in digital implementation of all best practices and improvement in Embedded Testing by scaling Team with upskilling and concept familiarization. * Participated in daily reviews between development, system engineers and test teams to downsize impediments. Generated, analyzed and presented POC, SOW, Techno-Commercial Proposal, Risk Assessment, DFMEA, FMEA, PFMEA, Test Plans, Protocol Results and different Status Reports to Product Delivery and On-shore teams. * Mentored more than 60 folks in Organizations so far in Agile Transformation being Agile Coach and helped Organization in Digital Transformation. Post Agile scaling Team with MS Azure cloud understanding and utilization effectively in projects. Show less

Roche
Oct 2022 - nowTechnical Lead - Test
Licenses & Certifications
- View certificate

Scrum Fundamentals Certified (SFC)
SCRUMstudy - Accreditation Body for Scrum and AgileDec 2020 - View certificate

Professional Scrum Product Owner
Scrum.orgOct 2020 - View certificate

Azure Active Directory: Basics
LinkedInJul 2020 - View certificate

Microsoft Certified: Azure Fundamentals
MicrosoftSept 2020 
ISTQB
Indian Testing BoardAug 2012- View certificate

Learning Azure Management Tools
LinkedInJul 2020 - View certificate

Introduction to Cloud Computing for IT Pros
LinkedInJul 2020 
HL7 V2.7 Workshop
HCit Consultant - IndiaMar 2015
ICP-ACC
ICAgileJan 2021- View certificate

Learning Cloud Computing: Core Concepts
LinkedInJul 2020
Languages
- enEnglish
- hiHindi
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