Senior Principal Quality Engineer - Twin Cities, MN

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.

The Senior Principal Quality Engineer - Twin Cities, MN role offers an outstanding opportunity to lead groundbreaking efforts in product development and sustainment within Baxter's or equivalent experience innovative environment. Located in Plymouth, this position allows you to contribute to the creation and maintenance of medical devices that meet the highest standards of quality and regulatory compliance. Join our ambitious team and be an integral part of our journey to deliver flawless medical solutions.

• Work closely with product engineering to support Product Life Cycle Management (PDLM) activities, including generating Design Plans and reviewing design inputs, outputs, verification, validation, and design transfer strategies, including risk management.
• Manage activities of self and others in achieving defined quality goals in an efficient, accurate, and timely manner.
• Provide support to product sustaining engineering specifically through risk and change control management.
• Provide support to post-market activities such as complaint investigations, complaint trending, NCR / CAPA, and FA processes as necessary.
• Provide informed recommendations to DHF and risk remediation activities.
• Act as a domain expert and play a crucial role in compliance audits and FDA/Ministry of Health inquiries.
• Provide mentorship and training to project personnel, ensuring they understand how to effectively apply design, statistical, and analytical tools.
• Offer technical support and mentorship for monthly Product Quality Data Reviews.
• Support audit and compliance activities at the site.
• Assist in decision-making for process improvement efforts.
• Mentor others in the areas of Quality Engineering and Quality Management System regulations.
• Ability to work under deadlines and changing priorities with minimal supervision.

• B.S Degree in engineering.
• Requires 10+ years of experience in Quality, Manufacturing, Engineering in the Medical Device industry. Cross-industry experience is a plus (e.g., automotive, aerospace, combination products).
• Medical Device regulatory experience preferred (FDA, EU MDR, etc).
• Proficiency in Excel required.

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 our employees, and we strive to be more transparent with our pay practices. To that end, this position has a base salary range of $120,000 to $165,000 plus an annual incentive bonus and equity target. The above range represents the expected base salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location.

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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.

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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.

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