Engineer II System VV
Engineer II 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.
Your Role at Baxter:
The role of V&V Engineer II is to independently Verify and Validating the device with minimal / no supervision. In addition to providing technical support and service in these areas the incumbent may also perform the following functions: requisitioning defining initiating specifying documenting and training.
This position is based out of Bangalore and reporting to the V&V Manager for PSS/GSS unit 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
- Support compliance/ closure of Regulatory and Quality requirements before completing Design Outputs/ Program Deliverables.
- Support 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.
- 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
- Participate in V&V development process improvement and test automation.
- Maintains awareness of current regulatory trends and their impact on the Verification and validation status of equipment and processes.
- Support the SMEs on Regulatory responses and Audits as needed
- Adheres to Baxter Quality Management system & supports the quality audits.
- 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 V&V Manager for PSS/GSS. 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
- 3 to 7 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.
- 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
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.
Employment Type
Full-Time
