- I M O N B I S W A S D E Y -

(Visa Status - Open Work Permit for Canada)

Location: 12 York Street, #504, Toronto, Canada • Contact: +1-437-***-**** • Email: ad3mv2@r.postjobfree.com LinkedIn: https://www.linkedin.com/in/imon-biswas-dey-904209178/ P ROFILE S UMMARY

• Dynamic and passionate Senior Software Engineer with 7+ years of experience in embedded medical device testing, emphasizing Class III devices

• Proficient in establishing and implementing Verification and Validation plans and reports and maintaining DHF

• Expertise in adhering to regulatory guidelines including FDA, EU-MDR, PMDA, and 62304

• ISTQB certified with advanced certification in progress, skilled in Agile and SCRUM methodologies

• Proven leadership in managing and guiding cross-functional teams in complex project environments

• Strong aptitude for software testing, particularly in the Medical Health Care Domain

• Capable of translating intricate product requirements into effective test protocols and methodologies

• Adept in formulating usability and formative testing protocols, contributing to product innovation and quality

• Proficient in leveraging tools like JIRA, SQL Server, HP ALM, and Visual Studio for optimal testing outcomes

• Experienced in leading projects focused on Ortho Knee and Hip planning, enhancing product development and testing processes

• Holds an open work permit visa for Canada

A R E A S O F E X P E R T I S E

Software Testing Manual Testing Mobile Testing Agile Methodology Scrum Development SDLC (Software Development Life Cycle) STLC

(Software Testing Life Cycle) Verification & Validation Usability Testing Human Factor Engineering quality system integration Test Protocol Design Team Management New Product Development (specifically for Class III embedded medical devices) Regulatory Guidelines Adherence

(FDA, EU-MDR, PMDA, 62304) Problem-Solving Compliance Communication and Collaborations Windchill(PLM) T E C HNICAL F ORTE

Tools: JIRA, SQL Server, HP ALM, XMind, Zphyr, Clear Quest, Rally, TFS, Visual Studio, Eclipse, Kanban, Jama, Windchill Environments: Windows XP/7/8/10, Windows Server, Linux Standards: HIPPA, DICOM, EMR, HL7, ISO Standards, DHF E DUCATION

• Bachelor of Technology/Bachelor of Engineering from West Bengal University of Technology (WBUT), India – 2016 C E R T I F I C A T I ONS

• Acquired Software Tester Certification from the International Software Testing Qualifications Board (ISTQB) A C H I E V EMENTS

• Spearheaded development and testing of Class III medical devices at Stryker, enhancing product functionality and compliance

• Successfully led a 4–5-member team at Stryker, driving efficient project management and team productivity in Ortho Knee and Hip planning

• At Siemens Healthineers, streamlined test case development for medical imaging software, elevating software quality and standards

• Advanced testing efficiency at Capgemini through the creation of test plans and documentation, leading to improved project outcomes

• Achieved ISTQB certification, demonstrating expertise and commitment to the software testing field P ROJECT H A NDLED

Title: Advanced Software Solution for Medical Imaging Post-Processing Duration: 1549 Days

Description:

• Engaged in an intricate medical imaging initiative focusing on post-processing

• Actively contributed to 3 comprehensive Software Testing Life Cycles (STLC)

• Collaborated seamlessly with Business Analysts and the core team to crystallize project requirements

• Executed in-depth testing across various facets, including integration, usability, performance, and user acceptance, ensuring robust software performance and reliability

P ROFESSIONAL E X P E R I E N C E

Stryker Global Technology Center Jul 2022 – Feb 2023 Designation: Senior Software Engineer - Software Testing Responsibilities & Accomplishments:

• Leveraging comprehensive knowledge in the development of Class III embedded medical devices, both hardware and software

• Serving as a pivotal contributor and leader, focusing on incorporating customer feedback and utilizing Cadaver research

• Continuously translating product requirements into actionable test protocols and methods for innovative software products

• Diligently applying software testing methodologies and adhering to ISTQB guidelines to design tests that ensure environmental adaptability, dependability, and compliance with safety/regulatory standards

• Experience with writing 510(k) submissions and Letters to File

• Managing the creation and completion of Validation Plans, Equivalency Reports, and other key validation documentation

• Championing the development of Usability-Formative and Summative testing protocols

• Overseeing and providing direction to the team in the execution of Verification reports

• Assisting with defect documentation in JIRA, collaborating with the Change Control Board to evaluate defect priority and severity

• Directing a cross-functional team of 4-5 members, concurrently managing projects related to Ortho Knee and Hip planning

• Contributing to the development of traceability documentation, including manufacturing traceability records

• Engaging in advanced formative and summative studies, partnering closely with Cadavers and Surgeons for optimum results

• Consistently ensuring open and motivational communication within the team to maintain high morale and productivity Siemens Healthineers May 2019 - Jul 2022

Designation: Software Test Engineer

Responsibilities & Accomplishments:

• Acquired hands-on experience with Medical Imaging post-processing software

• Analyzed business requirements meticulously, and subsequently developed test case scenarios, protocols, and manuals

• Reviewed both requirement documents and test specifications to ensure alignment

• Identified and reported crucial defects, elevating software quality and efficiency

• Carried out rigorous verification and validation of life-critical defects

• Detected and highlighted any deviations from established software standards.

• Familiarity with MDR requirements for obtaining CE mark and other global regulatory jurisdictions

• Expertise in adhering to regulatory guidelines including FDA, EU-MDR, PMDA, 21 CFR 820, ISO13485 and 62304

• Spearheaded the documentation of test reports and technical manuals, ensuring accuracy and completeness

• Crafted and executed comprehensive test scripts with precision

• Oversaw the maintenance and installation of various software applications, ensuring system stability and optimal performance

• Collaborated in the prototyping of vital product features, ensuring a proactive approach to product development

• Played an integral role in assuring the release quality, ensuring products met the highest standards

• Engaged closely with diverse stakeholders throughout the project's developmental life cycle, fostering collaboration and cohesion

• Initiated creating pivotal documents, including the Traceability Matrix, Test Readiness Report, Impact Analysis, and Test Summary

• Provided strategic recommendations for future systems, applications, and processes to elevate business efficiency

• Achieved the ISTQB certification and was in pursuit of the Agile Tester certification

• Concurrently, honed expertise in SQL, deepening technical knowledge and enhancing further skill set Capgemini Technology Services India Dec 2016 - May 2019 Designation: Associate Consultant

Responsibilities & Accomplishments:

• Contributed to the Monitoring Solutions Project at a prominent healthcare MNC, ensuring alignment with industry best practices

• Skillfully crafted and executed detailed manual test scripts, enhancing testing efficiency

• Spearheaded the creation of exhaustive test plans, closely followed by meticulous documentation of execution reports

• Identified and reported key defects, always aiming to uplift software quality and reliability

• Diligently maintained essential assets that supported test cases and the corresponding data

• Engaged and collaborated with diverse stakeholders throughout various phases of the project's developmental life cycle

• Worked in coordination with Software Engineers and Product Owners, fostering mutual understanding and efficient issue resolution

• Expertly diagnosed, reported, and monitored challenges raised in the tracking software, ensuring swift and effective solutions

• Pioneered the development of matrices aimed at augmenting test coverage and ensuring comprehensive evaluation

• Oversaw the meticulous installation and configuration of the test environment, guaranteeing optimal conditions for testing

• Played an instrumental role in shaping the planning and progression of the testing life cycle

• Took the initiative in documenting vital artefacts, ensuring transparency and traceability in all project phases

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