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\xe2\x80\x94where your purpose accelerates our mission.

The role of Senior V&V Engineer is to make technical contribution in understanding system 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.

This position is based out of Bangalore and reporting to the Software Manager for GSS and 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 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 V&V 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 with all relevant objective evidences

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 tests-related technical issues.

Presents the findings / objective evidences 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.

Your Team:

You will be reporting to Software Manager for 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\xe2\x80\x99ll Bring:

Bachelor\'s Degree in Mechanical engineering, Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field

6 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

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.

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

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 here and let us know the nature of your request along with your contact information.

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