Principal Engineer, V&V

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. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's 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.

Your Role at Baxter:

Baxter’s FLC portfolio represents a $1.2B business.  The products, used by clinicians in acute and ambulatory care settings globally, offer flexible solutions for both episodic and continuous monitoring workflows that measure pulse oximetry, non-invasive blood pressure (NIBP), temperature, and more.  They provide wired and wireless EMR connectivity utilizing encryption to give caregivers protected access to real-time patient information, as well as compatibility with Active Directory and Single Sign On to provide quick and secure access for clinicians.  Other features provided like cardiac assessment, early warning scores, and EtCO2 can help ensure the safety for higher risk patients by identifying patient deterioration.

Position Overview

A Principal Engineer, V&V will be responsible for verification of 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

• Bachelor's Degree in Software Engineering, Computer Science, Bio-Medical or related field.
• 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.
• Worked in Global environment

A Career That Matters

Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.

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.