Vantive: A New Company Built On Our Legacy

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

Your Role at Baxter

This is where your creativity addresses challenges

You are creative, thorough, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next. As a Sr. Principal Quality Engineer, you are unafraid of navigating through necessary internal processes to facilitate a product you deeply believe in. You can absorb and act on complex procedures and data and train your team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality.

Your Team at Baxter

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products.

We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.

Senior Principal Quality Engineer will Provide technical leadership in execution and improvements for Device Engineering Product Risk Management.

What you'll be doing

• Lead teams in hazards & harms analysis, risk assessments, creation/derivation of FMEAs, and linkage with Manufacturing & Service processes.
• Drive Risk competencies, consistency of tool usage, and execution deep into the DNA of Device Engineering.
• Applies a deep understanding of standards and practices in Risk Management and Reliability Engineering toward the development of new or existing products or processes.
• Accountable for audit defense of the Risk Management deliverables and activities at a Design Center.
• Drives process harmonization for Risk & Reliability within a Design Center, in collaboration with other Design Centers and functions.
• Responsible for operationalization and continuous improvement of Risk and Reliability Post Market monitoring mechanisms.
• Leads and coaches teams in the development/maintenance of Therapy and Product Risk Management deliverables
• Establishes Operating Mechanisms for long-term sustainability and integrity of Product Risk Management Files.
• Inside the business, contributes as an expert within area of technical specialty as evidenced by requests for guidance by fellow employees as well as others outside the division.
• Incorporates knowledge of customer use and product design to predict product effectiveness and anticipate potential failures.
• Provides technical input to strategic planning regarding Risk and Reliability deliverables.

What you'll bring

• BS degree in Engineering and minimum 10 years of relevant experience preferred or MS degree in Engineering and minimum 8 years of relevant experience in a highly regulated industry such as FDA, aerospace, telecom, or nuclear with a thorough understanding of the regulations, standards, and quality management systems.
• Development of Technical Requirements and Product Specifications
• Risk Management/ FMEA
• Design Verification and Design Validation
• Statistical Analysis with proficiency in excel
• Design Reviews, Design Transfer Activities, Design History File Management
• Complaint and Change Management
• Knowledge of the global Regulatory and Quality requirements for medical devices including: 21 CFR Parts 820, 803, & 806, ISO 13485, ISO 14971, IEC 62304, MDD 93/42/EEC and EU MDR 2017/745
• Strong analytical skills and the ability to teach others
• Excellent verbal, written communication skills.
• Experience with FDA inspections and ISO/ Notified Body audits
• ASQ (e.g., CQE, CMQ/OE, etc.) and/or Six Sigma certification highly preferred.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $104,000-$143,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law 
EEO is the law - Poster Supplement
Pay Transparency Policy

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.