Principal Engineer, V&V
Req #: 170006XB_en
Location: Bangalore, KA IN
Job Category: Research and Development
Date Posted: 9/26/2017 8:01:13 AM
Baxter International Inc. provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; bio-surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s 50,000 employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
Baxter has long been on the forefront of developing innovative solutions for patients with kidney disease. This job offers a unique and exciting opportunity to contribute in the design, development and life cycle management of Baxter’s products.
Baxter R&D India is looking for a highly talented individual who has the at most passion to find the faults, break the system to drive the quality with the commitment to deliver the safe and reliable product to save and sustain lives of the patients.
The successful candidate will possess solid “hands-on” technical abilities, an excitement and energy for product verification, and a passion for their work and the impact it has on meeting the needs of patients.
He/She will be responsible for understanding the product requirements & developing/updating the test protocols & procedures for the new &/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.
Essential Duties and Responsibilities:
- Own and lead all activities of design verification and validation throughout product life-cycle management.
- Responsible for building the overall test strategy & test automation to enhance the test efficiency
- Lead the development and documentation of the design verification plans, design validation plans and final test reports. Manage test related anomalies
- Lead the development and documentation of verification & validation test methods, protocols and test traceability
- Interact with systems engineers to ensure requirements are testable.
- Manage system integration activities to minimize issues in system verification and validation testing
- Direct/lead junior technical team members within area of responsibility to complete projects with quality, within time, and budget boundaries
- Develop and maintain an effective and collaborative working relationship with internal and external development partners. Leverage the talent and processes effectively
- 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
- Drive 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.
- Work 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 practices are followed along with the quality of testing
- Lead & Drive continuous improvement in process and product quality
- Be instrumental in developing the Verification & Validation methodologies in accordance with applicable Quality/Regulatory requirements and industry best practices
- Identify and report any quality or compliance concerns and take immediate corrective action as required.
- Support compliance/closure of Regulatory and Quality requirements before completing Design Outputs/Program Deliverables
- Maintains understanding of current regulatory trends and their impact on the Verification and validation status of equipment and processes.
- Support on-going regulatory agency inspection readiness through the self-assessment program to include mock inspections and compliance with revised and emerging regulations.
- Adheres to Baxter Quality Management system & supports the quality audits
Bachelor's Degree in Mechanical engineering, Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field
8+ yrs of relevant technical experience with working exposure of product design, development & testing
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 – testing complex medical(or similar) products, building test strategy & test plans, understanding applicable standards and regulatory requirements & translating them into test cases
- Experience in - writing system, subsystem-level and module level verification and validation 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.
- Experience with DOORS and JIRA a plus.
- Experience with production line testing a plus.
- Exposure to Six Sigma methodologies like DFSS, DFM, DFR etc is a plus
- Exposure and experience in BDD/TDD methodologies and test automation tools like Selenium, Cucumber, Junit etc is a plus