Engineer II – SW V&V, Digital & Applications

• 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 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.

What you'll 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 application, 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 of 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.