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    Sr. Eng V&V Testing - Bengaluru, India - Scalene works

    Scalene works
    Scalene works Bengaluru, India

    1 week ago

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    Description
    Position Overview

    A Senior Engineer, V&V will be responsible for verification of cardiology products and providing creative solutions for our new and existing product portfolio.

    The successful candidate will possess solid "hands-on" technical abilities, an excitement and energy for product development, and a passion for their work and the impact it has on meeting the needs of patients.


    Essential Duties and Responsibilities:

    • Formulate system verification strategy for a product.
    • Proven experience in testing and delivering medical devices to meet IEC/FDA/ISO standards.
    • Supports automation strategy and framework for the Software and System level testing.
    • Author, execute, perform, summarize, report out verification & validation test activities of components of a full system device; which includes but not limited to: Test Plans, Test Procedures, User and Functional Requirements testing, Design Verification, Installation/Operational/Performance Qualification Protocols, Traceability Matrices and Final Reports.
    • Pair up with design & development team to start the testing early in the design cycle to ensure the requirements testability, design traceability & test coverage. Refine the test plans and procedures through pre-verification/dry runs.
    • Identify and report any quality or compliance concerns and take immediate corrective/ preventive action as needed.
    • Review work products and ensure the quality of deliverables.
    • Participates in continuous improvement activities by identifying and appropriately escalating process and product quality gaps.
    • Supports the qualification of lab area, drive productivity improvement efforts, including testing, building fixtures, calibration, and data collection.
    • Ensures good documentation and good manufacturing practices are followed in the Verification and Validation Process.
    • Leads the investigations by identifying the root cause and drive solutions.
    • Supports the regulatory responses and audits (internal and external). Adheres to Quality Management system.
    • Participates in and contributes to the roadmap discussion.
    • Mentor peers/engineers in the stream of their expertise and on the processes.
    Qualifications / Experience and/or Background


    • Bachelor's Degree in Mechanical engineering, Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field.
    • 7 to 10 years of experience in Verification and validation testing of Software, Hardware and System.
    • Experience in design verification and validation of medical devices; and understanding of and adherence to FDA, ISO and IEC design control procedures, regulations, and standards.
    • Deep expertise in manual testing. Well versed with software and system testing techniques.
    • Experience in designing/scripting and executing automation tests is a strong plus.
    • Experience in writing system, subsystem-level and module level verification and validation plans, procedures, test execution and test report generation.
    • An understanding of test methods and processes as well as the methods used to verify product in the realms of software, mechanical, electrical, functional and environmental testing environments.
    Personal Characteristics


    • Excellent communication, inter-personal and leadership skills
    • Firm decision maker and shall possess good influencing skills
    • Openness to collaborate in interest of project/organization.
    • Proactive and self-driven, possesses due sense of urgency
    • Shall possess systems mindset and good problem-solving abilities.
    • Working with multisite teams, Quality conscious and Process & customer Oriented
    • Coaching capabilities.
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