Systems Engineer
Baxter International Inc.
Summary
As a Systems Engineer you will support the development activities for complex medical devices that meet customer needs and regulatory standards. This role works with talented systems, hardware and software engineers in resolving difficult problems by applying standard system engineering principles, methods, and techniques (Requirements and Risk Management, Issue Management, Configuration Management) to ensure our products meet medical device design control best practices.
Job description
Your Role at Baxter
As a Systems Engineer you will support the development activities for complex medical devices that meet customer needs and regulatory standards. This role works with talented systems, hardware and software engineers in resolving difficult problems by applying standard system engineering principles, methods, and techniques (Requirements and Risk Management, Issue Management, Configuration Management) to ensure our products meet medical device design control best practices.
What you'll be doing
- Lead development of Design Inputs and Digital Interface Requirements.
- Work with cross functional team members (e.g., Marketing and Clinical personnel) to translate user needs into system requirements.
- Lead engineering resources (Electrical, Mechanical, and Software) in the decomposition of system requirements to derived requirements.
- Contributes to resolution of competing constraints among inter-related functions (e.g., engineering, manufacturing, regulatory, marketing) required to deliver products to market.
- Resolves interface issues and have the ability to document theory of operations of complex medical product designs.
- Work with verification engineers to define test strategies for the development of verification plans and validation plans using requirement tracing methods.
- Support risk analysis activities from the capture of inherent hazards through mitigation, including quantitative residual risk calculation in support of the Safety Assurance Case.
- Implement configuration management through the complete product life cycle, including design, development, and sustaining phases.
- Interface with Manufacturing, Service, Product Surveillance, Supply Chain, and Customer Training staff through the design transfer process.
- Ensure compliance to the product development process and Quality System.
What you'll bring
- Bachelor's degree required with 2+ years of experience or Masters with 1+ years of experience.
- Solid understanding of systems engineering principals and related disciplines, Electro/Mechanical, Digital Interface, Fluid Mechanics, Materials Science, etc.
- Success in delivering results on technical challenges including investigative and problem-solving skills (DFSS/DMAIC/CAPA).
- Prior medical device preferred, Infusion Pumps and Syringe Pumps is a plus.
- Good communication skills, both oral and written.
Requirements
- Bachelor's degree required with 2+ years of experience or Masters with 1+ years of experience
- Solid understanding of systems engineering principals and related disciplines, Electro/Mechanical, Digital Interface, Fluid Mechanics, Materials Science, etc.
- Success in delivering results on technical challenges including investigative and problem-solving skills (DFSS/DMAIC/CAPA)
- Prior medical device preferred, Infusion Pumps and Syringe Pumps is a plus
- Good communication skills, both oral and written
- Applicants must be authorized to work for any employer in the U.S.
Benefits
- Medical, Dental & Vision
- Life & Accident Insurance
- Short & Long-Term Disability
- Business Travel Accident Insurance
- Employee Stock Purchase Plan
- 401(k) Matching
- Flexible Spending Accounts
- Educational Assistance
- Paid Holidays
- Paid Time Off
- Family & Medical Leave
- 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.