Principal Engineer, Test

Job Description

A Principal Engineer, V&V will be responsible for verification of cardiology products and providing creative solutions for our new and existing product portfolio. The successful candidate will possess solid hands-on technical abilities, an excitement and energy for product development, and a passion for their work and the impact it has on meeting the needs of patients.Essential Duties and Responsibilities:
• Formulate end to end system verification strategy for a product. Takes complete ownership of testing a product or release and ensures high quality deliverables.
• Proven experience in delivering medical devices to meet IEC/FDA/ISO standards and working closely with the regulatory bodies and affiliated labs.
• Develop automation strategy and framework for the Software and System level testing.
• Author, execute, perform, summarize, report out verification & validation test activities of components of 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.
• Pair up with design & development team to start the testing early in the design cycle to ensure the requirements testability, design traceability & test coverage. Refine the test plans and procedures through pre-verification/dry runs.
• Identify and report any quality or compliance concerns and take immediate corrective/ preventive action as needed.
• Review work products and ensure the quality of deliverables.
• Participates in continuous improvement activities by identifying and appropriately escalating process and product quality gaps.
• Lead the qualification of lab area, drive productivity improvement efforts, including testing, building fixtures, calibration, and data collection.
• Ensures good documentation and good manufacturing practices are followed in the Verification and Validation Process.
• Leads the investigations by identifying the root cause and drive solutions.
• Leads the regulatory responses and audits (internal and external) from the front. Adheres to Baxter Quality Management system & front ends the quality audits.
• Participates in and contributes to the roadmap discussion.
• Mentor peers/engineers in the stream of their expertise and on the processes.
Qualifications / Experience and/or Background
• Bachelors Degree in Mechanical engineering, Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field.
• 12 to 15 years of experience in Verification and validation testing of Software, Hardware and System.
• Experience in design verification and validation of medical devices; and understanding of and adherence to FDA, ISO and IEC design control procedures, regulations, and standards.
• Deep expertise in manual and automation testing. Well versed with software and system testing techniques.
• Experience in writing system, subsystem-level and module level verification and validation plans, procedures, test execution and test report generation.
• 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.
• Familiarity with reliability theory and analysis.
• Experience in technically leading a team of test engineers.
Personal Characteristics
• Excellent communication, inter-personal and leadership skills
• Firm decision maker and shall possess good influencing skills
• Openness to collaborate in interest of project/organization.
• Proactive and self-driven, possesses due sense of urgency
• Shall possess systems mindset and good problem-solving abilities.
• Working with multisite teams, Quality conscious and Process & customer Oriented
• Coaching capabilities.
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