Principal Eng System V&V

The role of Principal V&V Engineer is to independently develop a strategy for the Verification& Validation and execute it. You will be working closely with global cross-functional teams, third party labs and external certification bodies to realize the strategy and deliver the scope on time with the right quality. This position is based out of Bangalore and reporting to the Systems V&V Manager for PSS/GSS division of HST.

Essential Duties and Responsibilities:

• 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.
• Works independently with the team(s) and / or leads the team on the deliverables. Responsible for defining scope of work for project based team.
• Develops and manages processes and tools required to support the product in alignment with the global strategy.
• Participates and contributes in the roadmap discussion.
• Lead the qualification of lab area, productivity improvement efforts, including testing, building fixtures, calibration and data collection.h
• Leads the investigations by identifying the root cause and drive solutions.
• Manage the scope effectively, working closely with third party Vendors and Certification bodies
• Ensures good documentation and Good Manufacturing practices are followed in the Verification and Validation Process.
• Responsible for test suite development of state-of-the-art industry expertise and driving continuous improvements.
• Develop automation Framework for the Software and System level testing
• Proven experience in delivering healthcare devices to meet IEC basic safety, EMI-EMC standards and working closely with the regulatory bodies and affiliated labs
• Leads the regulatory responses and audits (internal and external) from the front.
• Adheres to Baxter Quality Management system & front ends 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-verification / Dry runs.
• Interacts with design team to resolve tests-related technical issues.
• Mentor peers / Engineers in the stream of their expertise and on the processes.
• Identify and report any quality or compliance concerns and take immediate corrective / Preventive action as needed.

Qualifications:

• Experience in medical device or similar product development, design verification/validation, system 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

Education and Experience:

• Bachelor's Degree in Mechanical engineering, Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field
• 10 to 15 years of experience in Verification and validation testing of Software, hardware and System.
• Relevant technical testing/reliability experience in electro-mechanical, electrical, or software 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.