Medical Device Client Manager

HASSAN DINESH-MOHAN

Client Manager

Fremont, CA *4536 *********@*****.*** 510-***-****

SUMMARY

● Executed audits to Regulatory Standards for Medical Device by ISO, EU, Health Canada, FDA, TGA, ANVISA and PDMA Organizations.

● Generated and executed Protocols, GXP Analysis, Validation Plans, Test Matrices and Validation Reports for Software used in Medical Devices.

● Experience of collaborating with Offshore Development Teams, Training new personnel and acting as Point-Of-Contact for daily updates.

TECHNICAL SKILLS

Platforms: Windows 11/10/7/Vista/XP, UNIX, LINUX

Mobile Platforms: Windows Mobile, iOS, Android OS

Programming: Java, HTML, XML, SQL, Shell script

Test Automation: Selenium/Webdriver, Junit, TestNG, Jenkins Database: Oracle, MySQL

Data Analysis: Tableau, Excel, Minitab, JMP, Six Sigma PLM Tools: Agile, Arena & ETQ

Web Tools: SDK Tools, FireBug

Browsers: MS Internet Explorer, Mozilla Firefox, Chrome, Safari, Opera Bug Tracking: Jira, ClearQuest, Mantis

Regulatory: ISO 9001, ISO 13485, MDSAP, MDD, MDR, IEC 62304 AUDITING EXPERIENCE:

BSI America - Herndon, VA (Home Based)

Client Manager Jun 2018 to May 2022

BSI America is a global business services organization, respected worldwide for the development of standards, assessment of management systems, testing and certification of products and services, providing software solutions, and the delivery of training courses..

● Responsible for delivering audit services to assigned clients in accordance with all BSI scheme and regulatory requirements to assure timely and cost effective service delivery.

● Executed more than 400 Medical Device audit assignments with clients that included companies of all sizes including QMS, CAPA, NCRs, Design requirements, Design specifications, Receiving Inspection, Manufacturing, Maintenance and Servicing.

● Served as BSI knowledge expert in High Risk Software, Active & Passive Medical Devices, Metal, Plastics, Chemicals and Pharmaceuticals empowering clients to make excellence a habit through effective auditing services.

● Regulatory standards included ISO 9001, ISO 13485, MDSAP, MDD, MDR and IEC 62304. 1

INDUSTRIAL EXPERIENCE:

Mizuho America Inc - Union City, CA Dec 2023 to Aug 2024 Design Engineer Documentation Specialist

Mizuho America, Inc. collaborates with surgeons to provide the best in class neurosurgical devices in order to advance surgical techniques and improve patient health.

● Improved compliance activities related to Design History Files, CAPA, Non-Conformances, Complaints, Internal Audits and Supplier Files.

● Reviewed and approved change orders, collaborated cross-functionally to improve implementation of requirements in various global regions. bluDiagnostics LLC - Cupertino, CA Jun 2022 to Apr 2023 Software QA Consultant (Full-Time)

bluDiagnostics LLC is an IVD company that develops devices aimed at fertility monitoring and measurements.

● Verified against specifications for the SiMD (Software In Medical Device) by generating and executing Test Protocols, meeting IEC 62304 regulations.

● Generated Test Plans for IQ, OQ and PQ and executed the same for a change in version of the

'Change Control Software Application' used by the company.

● Generated URS and FRS for various infrastructure software tools related to Purchasing, Vendor Management and Advertising, followed by GXP Analysis, Validation plans for IQ, OQ, PQ, Test Matrices and Validation Report.

Cepheid - Sunnyvale, CA

Software QA Engineer Sep 2017 to Feb 2018

Cepheid is a molecular diagnostics company that develops, manufactures and markets fully integrated systems for testing in the clinical and non-clinical markets.

● Tested a Medical Device Manufacturing Software by executing several protocols and filed the defects.

● Interfaced daily with the Development team to follow up on the defects status to bring them to closure.

Scanadu - Sunnyvale, CA Apr 2016 to Jun 2016

Software QA Consultant (Full-Time) Dec 2016 to Aug 2017 Scanadu is developing next generation tests, devices, and services that empower anyone to monitor and better understand their own health - anytime, anywhere.

● Executed the Mobile testing on Android devices of a Medical Device Software Measurement Application.

● Executed Functional testing of a Salesforce application for customer support and provided input for improvements.

● Automated the e-commerce application for functional tests using Selenium/Webdriver in Java and Junit.

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● Executed the IQ, PQ And OQ testing of a Medical Device Software Measurement Application and generated the respective reports.

● Conducted Pre-Audit preparation for ISO audit and ensured successful passing of the Audit within the designated timeline.

Abbott Diabetes Care - Alameda, CA Jul 2016 to Nov 2016 Software QA Consultant (Full-Time)

Abbott is a global leader in diabetes delivers the highest quality glucose monitoring products to the customers.

● Executed Computer System Validation of a Cloud Complaints Windows application for Medical Device by using Protocols, Test Matrices and Validation Summary Reports.

● Utilized HP-ALM and ClearQuest for Managing Defects generated during testing and tracked them to closure after verification of fixes.

● Proficient in installations of new builds of Software after defects have been fixed for verification and closing.

Proteus Digital Health - Hayward, CA Aug 2015 to Mar 2016 Software QA Engineer

Proteus Digital Health, Inc. focuses on developing products, services, and data systems based on integrating medicines with ingestible, wearable, mobile, and cloud computing applications.

● Generated Test Plans, Test Matrices and Release Reports from requirements for testing of Windows applications used in medical devices following SDLC methods.

● Executed the Validation and Verification of medical chip application by simulation and laboratory evaluations.

● Exposed to regulatory guidelines for Medical Device Software by FDA, IEC and ISO organizations.

● Extensively used Jira & Confluence for daily defects filing, bug tracking, tasks updates and projects status.

● Tested a software application used for Non Volatile Memory naming of sensors to be manufactured from wafers using cGMP requirements.

EDUCATION

M.S., in Chemical Engineering Texas A & M University Kingsville, TX B.S., in Chemical Engineering Bangalore University Bangalore, India Certificate in QA Testing of Computer Software Portnov Computer School Los Altos, CA Certified as ‘Clinical Research Professional’ Kriger Research Center Online - 2024 3

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