Principal Risk Engineer

Your role at Baxter The Risk Engineer is responsible for leading and executing risk management activities for infusion pump systems throughout 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, such as ISO 14971. The engineer works with cross‑functional teams—including engineering, quality, regulatory, clinical, manufacturing, and service—to integrate risk management into product design, development, and post‑market activities. Responsibilities Lead risk management activities in accordance with ISO 14971 and corporate procedures, including 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 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 using appropriate severity and probability models, and provide decision support to management or post‑market monitoring. Update risk management files based on design changes and post‑market information to maintain ongoing product safety. Facilitate risk reviews and risk management team meetings. Train and mentor team members on risk management principles and tools. Qualifications Bachelor’s degree in Engineering (Biomedical, Mechanical, Electrical, Systems Engineering, Computer Science, or related field). 5+ years of 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 documentation. Excellent analytical, problem‑solving, and communication skills. Ability to manage multiple priorities and project schedules. Compensation Estimated base salary: $112,000 to $154,000 annually, subject to market data and other factors. The position may also be eligible for discretionary bonuses. Work Authorization 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. Benefits Baxter offers comprehensive compensation and benefits packages for eligible roles. Benefits include medical and dental coverage that starts on day one; life, accident, short‑term, and long‑term disability coverage; 401(k) retirement savings plan with company matching; employee stock purchase plan; flexible spending accounts; educational assistance; paid holidays; paid time off ranging from 20 to 35 days; family and medical leave; paid parental leave; commuting benefits; employee discount program; employee assistance program; and childcare benefits. Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic. Reasonable Accommodations Baxter is committed to providing reasonable accommodations to individuals with disabilities. If you need an accommodation during the application or interview process, please contact our recruitment team with the nature of your request. Recruitment Fraud Notice Baxter has identified incidents of employment scams. Please review our Recruitment Fraud Notice to protect yourself from fraudulent parties posing as Baxter employees or recruiters. #J-18808-Ljbffr Baxter