Job Description

This is where you save and sustain livesAt 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.About Us: Baxter's MissionAt 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. Youll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxters 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.Your Role at BaxterThis is where your work saves livesThe research we do and the products we develop improve outcomes for patients around the world. As a Principal Engineer at Baxter, your work contributes directly to making a significant impact on others. It's challenging work and you're not on your own. Our teams collaborate multi-functionally and lead by influence. Whether guiding a team through a project or handling direct reports, our research and development team is responsible for influencing others to achieve results.Our colleagues within our R&D organization desire to work on products that make a substantial difference in others\' lives. We are motivated by the power of teamwork and are natural leaders who are skilled at influencing others.When you join Baxter as a Principal Eng, you\'ll use your analytical approach to identify risks and opportunities for innovation quickly. Agile and willing to take action, you stay calm under pressure.Your TeamWhile everyone at Baxter has a shared passion for our mission, the R&D teams play a meaningful role in our ability to save and sustain lives. Scientists and engineers in R&D work together to develop, test, and launch products that improve patient care.We courage teamwork and collaboration and prioritize establishing relationships with each other. It's easy to do because we all share common traits of reliability, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable.Baxter understands that learning and development are important. Whether it's training, tackling toward a promotion, or gaining experience with other portfolios or business units, Baxter leaders frequently speak with their teams about how employees are trying to grow and how they can support those efforts. With the ability to chart your own path, the development opportunities are endless.What you\'ll be doing

• Review, Author, Implement, perform, summarize, report out software verification & validation test activities of software 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, Software reliability, and related V&V tasks.
• Participate in the development of software Verification & Validation methodologies in accordance with applicable Quality/Regulatory requirements and industry best practices.
• Diagnose, isolate and investigate problem reports. Drive product improvements and/or bug fixes.
• Participate in identifying software V&V scope by performing impact analysis by reviewing code changes for each release.
• Ensure good documentation practices are followed in the software 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 evidence.
• Adheres to Baxter Quality Management system & supports quality audits.
• Support ongoing 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 requirement 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
• 7 to 10 yrs of experience in software Verification and validation testing of Software.
• Relevant technical testing/reliability experience software testing.
• An understanding of test methods and processes for Software verification and validation.
• 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.
• Familiarity with reliability theory and analysis as it pertains to test quantities derived from reliability.
• Experience with BDD framework and worked on test automation using Python, Selenium, etc.
• 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 alignment to FDA, ISO and IEC design control procedures, regulations and standards.
• Proven experience in accomplishing objectives.
• Able to deliver on multiple projects simultaneously.
• Self-motivated with good social skills
• Good team player to achieve team goals and guide junior team members in the team.

Equal Employment OpportunityBaxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.Reasonable AccommodationsBaxter 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.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review ourReasonable AccommodationsBaxter 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.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our .

Baxter