Senior Risk Engineer

Baxter International Inc.•Round Lake, IL

1d•$96,000 - $132,000•Hybrid

About The Position

The Senior Risk Engineer is responsible for leading and accomplishing risk management activities for infusion pump systems throughout the product lifecycle. This role ensures patient and user safety by identifying hazards, assessing risks, and applying effective mitigation strategies. By following corporate procedures and industry standards, the Senior Risk Engineer collaborates with engineering, quality, regulatory, clinical, manufacturing, and service teams to incorporate risk management into product build, development, and post-market activities, all in support of ongoing product safety.

Requirements

Bachelor’s degree in Engineering or related field with 3+ years of progressive experience in medical device risk management or product development, including ownership of complex systems or programs.
Proven experience leading risk management activities across the product lifecycle using tools such as FMEA, FTA, and hazard analysis.
Advanced proficiency with requirements and risk management tools (e.g., DOORS), bug tracking systems, and end-to-end traceability and documentation in regulated environments.
Excellent analytical and data-driven decision-making skills, with the ability to independently assess risk, influence design decisions, and balance patient safety, product performance, and compliance.
Demonstrated ability to lead and influence cross-functional teams, communicate complex risk concepts clearly, and drive alignment across engineering, quality, and regulatory stakeholders.
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.

Responsibilities

Lead risk management activities following ISO 14971 and corporate procedures concerning 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 the build and development to ensure risk controls are incorporated, verified, and 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 using appropriate severity and probability models, ensuring risks are reduced to acceptable levels.
Update risk management files based on build changes and post-market information, ensuring ongoing product safety.
Facilitate risk reviews and risk management team meetings.
Train and mentor team members on risk management principles and tools.

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