Principal Engineer
Baxter International Inc.
Summary
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.
Job description
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).
Requirements
- B.S. in Engineering
- 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)
Benefits
- Medical coverage
- Dental coverage
- Life insurance
- Accident insurance
- Short-term disability
- Long-term disability
- Business travel accident insurance
- Employee Stock Purchase Plan
- 401(k) Retirement Savings Plan
- Flexible Spending Accounts
- Educational assistance
- Paid holidays
- Paid time off
- Family and medical leaves
- Paid parental leave
- Commuting benefits
- Employee Discount Program
- Employee Assistance Program
- Childcare benefits
Company overview
Baxter International Inc. is an American multinational healthcare company headquartered in Deerfield, Illinois, founded in 1931. As a leading global medical device manufacturer, Baxter specializes in developing and producing essential medical products for treating chronic and acute medical conditions. The company operates across three primary business segments: Medical Products and Therapies, Healthcare Systems and Technologies, and Pharmaceuticals. Baxter's extensive product portfolio includes intravenous (IV) solutions, infusion pumps, dialysis equipment for kidney disease treatment, surgical technologies, and hospital pharmaceuticals. With approximately 38,000 employees worldwide and annual revenues exceeding $10 billion, Baxter plays a critical role in global healthcare infrastructure. The company is particularly known for its leadership in IV fluid production, manufacturing approximately 60% of the intravenous fluids used in the United States. Baxter's innovations include pioneering developments in artificial kidney technology and advanced surgical products, serving healthcare providers across more than 100 countries. The company maintains a strong commitment to research and development, investing significantly in medical technology advancements that improve patient outcomes and healthcare delivery efficiency.