Principal Risk Engineer

Baxter International Inc.•Round Lake, IL

4d•$112,000 - $154,000•Hybrid

About The Position

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.

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.

Responsibilities

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

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