Software Validation and Verification Specialist

3 weeks ago

Bengaluru, Karnataka, India Baxter Full time

About Us: Baxter's Mission

Baxter is a leading medical technology company that has been pioneering significant medical innovations for over 85 years. Our mission is to save and sustain lives, and we are deeply connected by our shared purpose.

At Baxter, we believe that our work makes a positive impact on people around the world. Our products and therapies are found in almost every hospital worldwide, in clinics, and in the home. We are committed to improving healthcare outcomes for millions of patients.

About the Role

We are seeking a highly skilled Sr. Engineer SW V&V to join our team. As a Sr. Engineer SW V&V, you will be responsible for designing and developing model verification test protocols and procedures/scripts from requirement specifications. You will also be responsible for organizing and implementing test protocols and test procedures/scripts for embedded software.

Responsibilities

  • Review, Author, Implement, perform, summarize, report out SW verification & validation test activities of components to a Software application.
  • Design and develop model verification test protocols and procedures/scripts from requirement specifications.
  • Organize and implement test protocols and test procedures/scripts for embedded software.
  • Shares technical knowledge within the team.
  • Collect and analyze test results from model testing activities.
  • Will work closely with the software/model development team in reviewing specifications, writing test procedures, plans, entering product issues, and collecting completed test data/documentation for archiving.
  • Use MATLAB and Simulink Test for model-based testing activities.
  • Support compliance/ closure of Regulatory and Quality requirements before completing Design Outputs/ Program Deliverables.
  • Clear understanding of the elements of Risk Management, FMEA, Software reliability, and related V&V tasks.
  • Participate in the development of Verification & Validation methodologies in accordance with applicable Quality/Regulatory requirements and industry standard methodologies.
  • Diagnose, isolate and investigate problem reports. Drive product software improvements and/or bug fixes. Drive impact analysis by reviewing code changes for each release.
  • Ensure good documentation practices are followed in the Verification and Validation Process.
  • Adheres to Baxter Quality Management system & supports quality audits.
  • Pair up with design & development team to start the testing early in the design cycle to ensure the requirement's testability, design traceability & test coverage. Identify issues early to fix them. Refine the test plans and procedures through pre-verifications / Dry runs.
  • Interacts with design team to resolve tests-related technical issues.
  • Presents the findings / objective evidence and able to present with rationale with applicability / exclusions.
  • Identify and report any quality or compliance concerns and take immediate corrective / Preventive action as needed.

Requirements

  • Bachelor's degree in mechanical engineering, Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field or equivalent
  • 6 to 9 yrs of experience in Verification and validation testing of Software and System.
  • Proven experience with the MATLAB and Simulink Test software. Preferably hands on experience in building test models using MATLAB or Simulink.
  • Minimum 2 years of model-based test development and testing experience or equivalent education.
  • Experience working with Simulink model test harnesses.
  • Knowledge of Microsoft Office (Word, Excel, Outlook, Teams, etc.)
  • 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.
  • Experience in - writing Software, subsystem-level and module level verification and validation plans, procedures, Test Execution and Test report generation
  • Understanding of software product design methodologies and test practices.
  • Familiarity with reliability theory and analysis as it pertains to test quantities derived from reliability.
  • Experience in medical device or similar product development, design verification/validation, Software integration, risk management, reliability engineering, process validation and Quality systems.
  • Deep expertise in design verification and validation of medical devices is a plus.
  • Understanding of and alignment to FDA, ISO and IEC design control procedures, regulations and standards.
  • Proven experience in accomplishing objectives. Able to deliver on multiple projects simultaneously.
  • Self-motivated with good interpersonal skills

What you'll bring

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