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Baxter Logo Baxter · IT - Software Development

Principal Risk Engineer

United States, Round Lake Employment contract 112000.00 - 154000.00 USD / Year · Job Posted July 04, 2026
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Job Description

The Risk Engineer is responsible for leading and executing risk management activities for infusion pump systems through the product lifecycle. This role ensures patient and user safety by identifying hazards, assessing risks, and implementing effective mitigation strategies in compliance with corporate procedures and industry standards (e.g., ISO 14971) by working with engineering, quality, regulatory, clinical, manufacturing and service teams to integrate risk management into product design, development, and post-market activities in support of ongoing product safety.

Job Responsibility

  • Lead risk management activities in accordance with ISO 14971 and corporate procedures related to risk management plans, hazard analyses, FMEAs, fault tree analyses, and risk reports
  • Identify hazards associated with infusion pumps, including mechanical, electrical, software, usability, and cybersecurity-related risks
  • Collaborate with cross-functional teams during design and development to ensure risk controls are incorporated and verified and/or validated
  • Ensure traceability between hazards, hazardous situations, risk controls, and verification activities
  • Perform robust risk impact assessments of issue records, change controls, complaint trends and NCR/SNCs and other scenarios using appropriate severity and probability models and ensure risks are reduced to acceptable levels or provide decision support to management or post-market monitoring
  • Update risk management files based on design changes and post-market information and ensure ongoing product safety
  • Facilitate risk reviews and risk management team meetings
  • Train and mentor team members on risk management principles and tools

Requirements

  • Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical, Systems Engineering, Computer Science or related field)
  • 5+ years (senior-level) experience in medical device risk management or product development
  • Working knowledge of ISO 14971 and related standards
  • Experience with risk analysis tools (e.g., FMEA, FTA, hazard analysis), bug tracking tools, requirements management tools (e.g. DOORS) and traceability, and documentation
  • Excellent analytical, problem-solving, and communication skills
  • Ability to manage multiple priorities and project schedules
  • 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

What we offer

  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • 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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