Manjunath Mandre

About Manjunath Mandre

A highly skilled and talented professional experienced in Medical Devices.

Experience

1. Senior Engineer

   L&T Technology Services

   Mar 2022 — Present · Bengaluru, IN

   Roles & Responsibilities: Software Design Quality Engineer.Project 02: Software as a Medical Device.(April 2023 to till date)Creating and reviewing SDLC deliverables according to IEC 62304 (Plan, Input, Output, V&V, Transfer Phases) for Software as a Medical Device.Plan Phase: Updating Project approval form, Clinical & Regulatory Plan, Risk management plan, Cyber Security Risk Management Plan, Software development plan, D&D plan, Design Verification & validation plan documents.Input phase: Exporting user requirements & system requirements from Jira and mapping them accordingly.Input phase: Updating Software hazard analysis and cybersecurity FMEA.Output phase: Updating defect summary report by exporting the defects from Jira for previous version of software and providing rationale, software build report, Software Architecture and Detailed Design Specification, Software Configuration documents.V&V phase: Exporting the test cases & test results from Jira and updating verification & validation protocol and reports.V&V phase: Updating traceability matrix (Mapping requirements i.e URS & SRS with the testcases).V&V phase: Updating verification & validation summary reports.Transfer Phase: Updating risk management report, Product Deployment procedure & report, Design review checklist, Device Master Record documents.Working with Agile tool for Maintaining/Exporting the test cases and test results from Jira, Bugs tracking.Project 01: Complaint investigation & Vigilance Reporting.(Mar 2022 to April 2023)Creation, investigation and reporting of Medical Device Reporting (TrackWise tool) for submission to global authorities (Ex: eMDR, Korea, Malaysia, Australia, MIR, etc.) if incidents meet the reportable criteria for Malfunction.