Principal Systems Engineer

Baxter International Inc.Round Lake, IL

About The Position

At Baxter, every person deserves a chance to live a healthy life, a belief that has guided the company since 1931. Baxter is redefining healthcare delivery to make a greater impact, with colleagues united by the Mission to Save and Sustain Lives, driven by a culture of courage, trust, and collaboration. Individuals are empowered to take ownership and make a meaningful impact, striving for efficient and effective operations and accountability for exceptional results. As a Principal Systems Engineer at Baxter, your work directly contributes to improving outcomes for patients worldwide through research and product development. This challenging work is supported by cross-functional teams that collaborate and lead by influence. The R&D team is responsible for influencing others to achieve results, motivated by teamwork and a desire to work on products that make a meaningful difference in others' lives. In this role, you will support the development activities for complex medical devices, ensuring they meet customer needs and regulatory standards. You will work with systems, hardware, and software engineers to resolve difficult problems by applying standard system engineering principles, methods, and techniques, including Requirements and Risk Management, Issue Management, and Configuration Management, to ensure products meet medical device design control best practices.

Requirements

  • Bachelor’s degree required with 5+ years of experience or Masters with 3+ 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).
  • Good communication skills, both oral and written.

Nice To Haves

  • Prior medical device preferred
  • Infusion Pumps and Syringe Pumps is a plus

Responsibilities

  • 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.

Benefits

  • medical and dental coverage that start on day one
  • insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
  • 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
  • Flexible Spending Accounts
  • educational assistance programs
  • 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
  • paid parental leave
  • commuting benefits
  • Employee Discount Program
  • Employee Assistance Program (EAP)
  • childcare benefits
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