Job Description The role of Engineer II SW V&V Engineer (Digital) is to make technical contributions in understanding system and software 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. What you'll be doing 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. 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 practices are followed in the SW Verification and Validation Process Participate in continuous improvement activities by supporting the implementation of process and product quality improvement initiatives Participate in V&V development process improvement and test automation. Maintains awareness of current regulatory trends and their impact on the Verification and validation status of equipment and processes. Support the SMEs on Regulatory responses and Audits, as needed. 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 them. Refine the test plans and procedures through pre-verifications / Dry runs. Interacts with design team to resolve test-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. What youll bring Bachelor's degree in mechanical engineering, Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field 3 to 6 yrs of experience in Verification and validation testing of Software and hardware. Relevant technical testing/reliability experience in software testing & automation. Any scripting knowledge like python, shell etc. Good programming knowledge on selenium for automation testing. Experience in desktop applications, web application testing. Understanding of software architecture (web applications using Angular, microservice & cloud) Test framework development and test harness development knowledge. Knowledge on software in loop testing. Relevant technical testing/reliability experience in software testing and test methods and processes. Experience in - writing System, subsystem-level and module level software verification and validation plans, procedures, Test Execution and Test report generation. Understanding software product design methodologies and test practices. Experience in medical devices or similar products in software integration. 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 Good Team player.
