Principal Systems Engineer

BaxterRound Lake, IL
Hybrid

About The Position

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. Your role at Baxter As a Principal 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.

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.
  • 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.

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
  • 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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