Principal Engineer

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job-you will find purpose and pride. For a Baxter Containers Principal Engineer, understanding nDEHP (non-DEHP materials) and nitrosamines is important because both relate to patient safety, product quality, and regulatory compliance. Success in the role requires leading cross-functional efforts to assess risk, validate solutions, maintain compliance, and ensure uninterrupted product supply. What You’ll Do: Lead product and process development initiatives for IV solutions and delivery systems. Perform risk assessments related to materials, manufacturing processes, and patient safety. Evaluate and implement non-DEHP materials and alternative packaging solutions. Drive investigations and mitigation strategies for nitrosamine and other impurity risks. Partner with Quality, Regulatory Affairs, R&D, Operations, and Supplier Quality teams. Oversee validation, stability, compatibility, and extractables/leachables studies. Support regulatory submissions, audits, and global compliance requirements. Lead complex change management projects while maintaining product quality and supply continuity. What You’ll Bring: B.S. in Engineering and 7+ years of engineering experience in a regulated industry (medical device, pharmaceutical, biotech, healthcare, or related manufacturing environment). Experience leading cross-functional projects involving product development, manufacturing, quality, and regulatory teams. Strong knowledge of risk management, validation, design controls, and change management. Experience with materials, packaging, container-closure systems, and product lifecycle management. Familiarity with FDA, GMP, ISO, and global regulatory requirements. Ability to lead complex technical investigations and implement corrective and preventive actions (CAPAs). Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change. 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 $112,000-$154,000 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 upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. US Benefits at Baxter (except for Puerto Rico) This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. 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. Know Your Rights: Workplace Discrimination is Illegal 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. Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time. #LI-TV1 #J-18808-Ljbffr