Sr Eng Systems VV
Sr Eng Systems 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.
Posting Title: Senior Engineer Systems V&V GSS & PSS
Your Role at Baxter:
The role of Senior Engineer Systems V&V is to make technical contributions 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 Systems/V&V Manager for 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 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.
Participate in Lab area Setup for the division.
Lead 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.
Works with external test houses such as EMI EMC tests for electrical boards and full device) to define the test scope author the test plans test procedures execute & consolidate the reports.
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.
Experience in IEC basic safety EMIEMC standards.
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 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 them. Refine the test plans and procedures through preverifications / Dry runs.
Interacts with design team to resolve testsrelated 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.
Your Team:
You will be reporting to Systems/V&V 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 Youll Bring:
Bachelors Degree in Mechanical engineering Electrical Engineering Software Engineering Computer Science BioMedical Industrial Engineering or related field
7 to 10 yrs 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 products 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.
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 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.
Good team player to achieve team goals and guide new joiners or junior team members.
Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating inperson in support of our Mission.
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
Baxter 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 Recruitment Fraud Notice.
Required Experience:
Senior IC
Employment Type
Full-Time
