Location
India | India
Job description
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
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 Software manager GSS/PSS.
Essential Duties and Responsibilities :
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 , Regulatory, Performance 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 and priority 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 to the roadmap discussion.
Lead the qualification of lab area, productivity improvement efforts, including testing, building fixtures, calibration and data collection.
Leads the investigations by identifying the root cause and drive solutions.
Manage the Project scope effectively working closely with cross functional teams.
Ensures good documentation practices are followed in the software Verification and Validation Process.
Responsible for test suite design & development of state-of-the-art industry expertise and driving continuous improvements.
Design & Develop automation Framework for the Software and System level testing.
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 them . Refine the test plans and procedures through pre-verification / Dry runs.
Participate in identifying software Verification and validation scope by performing impact analysis by reviewing code changes for each release.
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.
Your Team:
You will be r eporting to Software manager GSS/PSS . This position does not have any direct reports. You will need to work collaboratively with R&D and cross functions .
Your Location:
The role is located in the BRD facility in Bangalore India .
What You’ll Bring:
Bachelor's Degree in Mechanical engineering , Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field
10 to 15 y ea rs of experience in Verification and validation testing of Software.
Relevant technical testing/reliability experience in software testing
An understanding of test methods and processes as well as the methods used to verify products in the realms of, software.
Experience in - writing system, subsystem-level and module level software 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, 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 .
Good team player to achieve team goals.
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
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