Sr. Engineer, Software V&V

The role of Senior V&V Engineer is to make technical contribution in understanding system requirements and developing/updating the test protocols & procedures for the new and / or existing products at Sub system and System level. It includes verification and validation, environmental, performance, reliability and safety/regulatory related tests and executing the same, documenting the reports.

This position is based out of Bangalore and reporting to the Software ManagerPSS.

Essential Duties and Responsibilities:

• Review, Author, Execute, perform, summarize, report out verification & validation test activities of components to 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.

• Support compliance/ closure of Regulatory and Quality requirements before completing Design Outputs/ Program Deliverables.

• Clear understanding of the elements of Risk Management, FMEA, critical / Essential parts identification, System reliability, Life / limits testing and related V&V tasks.

• Participate in the development of Verification & Validation methodologies in accordance with applicable Quality/Regulatory requirements and industry best practices

• Lead the qualification of lab area, productivity improvement efforts, including testing, building fixtures, calibration and data collection.

• Diagnose, isolate and investigate problem reports. Drive product improvements and/or bug fixes.

• Ensure good documentation and Good Manufacturing practices are followed in the Verification and Validation Process

• Participate in continuous improvement activities by supporting the implementation of process and product quality improvement initiatives

• Deep knowledge in test automation tools and realizing test automation suite.

• Work closely with the auditees to understand the details and support with all relevant objective evidences

• Adheres to Baxter Quality Management system & supports the quality audits.

• Support on-going regulatory agency inspection readiness through the self-assessment program to include mock inspections and compliance with revised and emerging regulations.

• Pair up with design & development team to start the testing early in the design cycle to ensure the requirements testability, design traceability & test coverage. Identify issues early to fix the same. 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 evidences 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.

Your Team:

You will be reporting toSoftware Manager for GSS/PSS. This position does not have any direct reports. You will need to work collaboratively with R&D and cross functions. 

Your Location:

The role is located inthe BRD facility in Bangalore India.  

What You’ll Bring:

• Bachelor's Degree in Mechanical engineering, Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field

• 6 to 10 yrs of experience in Verification and validation testing of Software and hardware.

• Relevant technical testing/reliability experience in electro-mechanical, electrical, or software testing.

• Understanding of hardware schematic diagrams and debugging tools like IC5000, CAN Analyzer, Trace 32, Keil IDE, PEAK analyzer, Oscilloscope 

• Any scripting knowledge like python, shell etc. Good programming knowledge and basic understanding of Embedded programming.

• Understanding of modeling ( MATLAB, Simulink etc ) 

• Test framework development and test harness development knowledge. 

• Knowledge on hardware in loop and software in loop testing.

• 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 system, subsystem-level and module level verification and validation plans, procedures, Test Execution and Test report generation

• Understanding of hardware and 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 (involving software & hardware), risk management, reliability engineering, process validation and Quality systems

• Deep domain knowledge in design verification and validation of medical devices is a plus

• Understanding of and adherence to FDA, ISO and IEC design control procedures, regulations and standards.

• Demonstrated experience in accomplishing objectives. Able to deliver on multiple projects simultaneously

• Self-motivated with good interpersonal skills