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 As a Principal Engineer, you will collaborate with your team to develop and maintain Peritoneal Dialysis (PD) disposable products. You will provide Quality Engineering leadership to ensure successful design, testing, and transfer of medical products. Your Team at Baxter Each role in Quality matters. Baxter delivers products globally to patients. Whether developing a new process or tackling a production obstacle, creativity is valued. Your role will have an impact on 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 build top-of-the-line products. The Renal Peritoneal Dialysis (PD) Product Quality Engineering Team is looking for a dedicated Engineer to support quality engineering product support activities. What you'll be doing Provide quality oversight and mentorship to project teams, ensuring that Quality Engineering principles are applied to develop and improve products that are robust, safe, and effective. Develop, review and approve DHF, DMR, risk management, verification, validation and other product development documents Ensure compliance to applicable Baxter policy, procedures and regulations Provide direction and critical reviews for Development Planning, Design Inputs, Design verification and Validation, Peer Technical and Design Reviews, Risk Management and Labeling review Collaborate with Baxter plant, external partners, and corporate groups to transfer new and improved products. Analyze manufacturing data, reports, statistics, and documentation to identify and address quality issues and process improvements. Offer mentorship to project personnel regarding the appropriate application of design, statistical, and analytical tools. Lead CAPA related activities as appropriate Monitor and report on critical metrics for CAPA during monthly governance meetings. Identify areas for improving regulatory compliance and continuous improvement opportunities for products and processes Compile trending information from quality inputs (nonconformance, FCA, complaints, MDR, etc.) using Microsoft Excel for sustaining products organization. Prepare and issue monthly PQDR (product quality data reports) based on information analysis Support both internal and external audits What you'll bring Bachelor's degree in Engineering (Biomedical, Mechanical or Electrical preferred) At least 8 years of experience in Quality, Engineering or Manufacturing or related field Relevant experience supporting products in a regulated environment is required. At least 4 years of Quality Engineering experience is preferred Understanding the global Regulatory and Quality require ents for medical devices, including ISO 13485, FDA Quality Systems Regulation, ISO 14971, MDD 93/42/EEC, EU MDR, and other relevant international laws. Outstanding problem-solving and analytical skills Excellent communication and interpersonal abilities Ability to perform multiple tasks simultaneously with compliance to Standard Operation Procedures and Regulatory requirements Ability to work collaboratively in a global and team-oriented environment Balance multiple activities, priorities, and deadlines Good technical skills (e.g. spreadsheet, databases and online research) Nice to have: Green Belt or Black Belt Certification desired Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. 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 to $143,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based 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. #LI-BG1 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. 143101 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