Sr Eng, Software V&V

• 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.

What you'll bring

• Bachelor's degree in 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