Principal Eng System VV
Principal Eng System VV
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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. 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 liveswhere 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 crossfunctional 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 stateoftheart 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 EMIEMC 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 ongoing regulatory agency inspection readiness through the selfassessment 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 preverification / Dry runs.
- Interacts with design team to resolve testsrelated 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
- Selfmotivated with good interpersonal skills
Education and Experience:
- Bachelors Degree in Mechanical engineering Electrical Engineering Software Engineering Computer Science BioMedical 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 electromechanical 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 subsystemlevel and module level verification and validation plans procedures Test and Test report generation
- Understanding of hardware and software product design methodologies and test practices.
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.
Recruitment Fraud Notice
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Required Experience:
Staff IC
Employment Type
Full-Time
