Principal Eng, V&V

Job Description

Principal Eng, V&VApply Now Save JobThis 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. 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.About BaxterBaxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis;sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacyautomation, software and services. The company s global footprint and the critical nature of its products and servicesplay a key role in expanding access to healthcare in emerging and developed countries. Baxter s employees worldwideare building upon the company s rich heritage of medical breakthroughs to advance the next generation of healthcareinnovations that enable patient care.Job Summary Job Title Principal Engineer, Verification Lead Location Whitefield, Bangalore Shift GeneralPosition OverviewAs Principal Engineer - System Verification and Validation (V&V) for Infusion pumps team within Medication delivery business, the incumbent will have an independent responsibility of following instructions clearly in executing Test procedures for supporting all activities related to Design Verification of the medical devices. Candidate will also assist in maintaining Lab equipment, work with Design engineers to help build Test fixtures/assemblies and assisting with Lab logistics.Essential Duties and ResponsibilitiesLead the system verification team to Execute, perform, summarize, report out verification test activities of components to a full system device: Which includes but not limited to:

• Understand URS (User requirements) / System Requirements and prepare the System Level Test cases and Prepare test procedures.
• Guide the team on proper verification approach, including unit, functional, regression and integration testing.
• Lead/Perform the Functional and Performance testing for the product.
• Lead/Support and perform Design Verification activites
• Lead/Support Perform Installation/Operational/Performance Qualification Protocols
• Prepare Traceability Matrices and Final Reports.
• Reporting to team and senior management on progress of verification, status of defects and general stability of application.
• Assist in logging defects in JIRA and assist Change Control Board in determining priority and severity of defects.
• Guide team on testing automation tools for future implementation to gain testing efficiency
• Compile Verification Test Summary Report at conclusion of formal verification phase for submission to medical device regulators
• Support compliance/ closure of Regulatory and Quality requirements before completing Design Outputs/ Program Deliverables.
• Follow Test instructions and Test protocols.
• Follow instructions clearly from Design engineers during Test execution.
• Support Design engineers in Test fixture creation, building up & tearing down Test equipment.
• Support Lab logistics and Support Calibration activities.
• Diagnose, isolate and investigate problem reports and defects.
• 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 Process
• Experience in IEC basic safety, EMI-EMC standards
• 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.

Qualifications / Experience and/or BackgroundBachelors Degree in Mechanical engineering, Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field10+ Years of experience in System Verification testing System functionality and performance.Relevant technical testing/reliability experience in electro-mechanical, electrical testing of Medical Devices.An understanding of test methods and processes as well as the methods used to verify product in the realms of; mechanical, electrical, functional and environmental testing environments.Hands on experience in data analysis of Performance testing and Sample size calculations for variable/Attribute dataExperience in Tools like Minitab( Data Analysis) / JIRA ( Defect ) / ALM ( test Environment) etc.Understanding of hardware and software product design methodologies and test practices.Experience in medical device or similar product development, design verification/validation, system integration (hardware/Subsystem/Software), risk management, reliability engineering, process validation and Quality systemsBasic understanding of and adherence to FDA,MDD/MDR, ISO13485 and IEC design control procedures, regulations and standards.Self-motivated with good interpersonal skills. Ability to follow instructions clearly.Reasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.039099Apply Now Save Job,

Keyskills :
test casesproduct designchange controldesign controlrisk managementtest procedurescomputer scienceautomation toolssenior managementpreventive actionsystem integrationprocess validation