Sr Engineer, V&V

Baxter

7 - 10 years

8 - 13 Lacs

bengaluru

Posted:1 day ago| Platform:

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Skills Required

matlab simulink risk management technical writing python software software testing keil ide manual testing automation medical devices test automation framework analyzer design debugging shell scripting validation testing embedded programming

Work Mode

Work from Office

Job Type

Full Time

Job Description

Review, Author, Execute, perform, summarize, report out verification validation test activities of components to a full system device: Which includes but is 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 VV 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 all relevant objective evidence
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 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
7 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 of hardware in loop and software in loop testing.
An understanding of test methods and processes as well as the methods used to verify products 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

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