Principal Engineer, V&V, Respiratory Health

Job Description

Principal Engineer, V&V, Respiratory HealthApply 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.Baxter s Respiratory Health business unit products expand therapies to better help patients andphysicians to manage chronic or acute respiratory and cardiac diseases (COPD, CHF, etc.). The earlier the treatment for these patients the better the quality of life. The $150M business portfolio includes products for airway clearance and ventilation.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 cross-functional 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 V&V Manager for Respiratory Health division of Front Line Care.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.
• 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 state-of-the-art 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, EMI-EMC 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 on-going 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 requirements testability, design traceability & test coverage. Identify issues early to fix the same. Refine the test plans and procedures through pre-verification / Dry runs.
• Interacts with design team to resolve tests-related 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.
Your Team:You will be reporting to V&V Manager for Respiratory Health. 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 You ll Bring:
• Bachelors Degree in Mechanical engineering, Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field
• 8 to 15 years of experience in Verification and validation testing of Software, hardware and System.
• Relevant technical testing/reliability experience in electro-mechanical, 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, subsystem-level and module level verification and validation plans, procedures, Test Execution 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
• Self-motivated with good interpersonal skills
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.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 .084802Apply Now Save Job,

Keyskills :
javalinuxjavascriptframeworkthird party vendorsverificationvalidationcontinuous improvement facilitationquality management systemroot causeproduct designtest execution