Senior Risk Engineer

About the role

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.

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.

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.

Qualifications

• Must be authorized to work for any employer in the U.S.

Skills

• Problem Solver
• Analytical Thinker
• Data Driven
• Solution Focused & Results Oriented
• Collaborative
• Innovative

Benefits

• Medical and Dental Coverage
• Insurance for Basic Life, Accident, Short-Term and Long-Term Disability
• Business Travel Accident Insurance
• Employee Stock Purchase Plan (ESPP)
• 401(k) Retirement Savings Plan (RSP)
• Flexible Spending Accounts
• Education Assistance Programs
• Paid Holidays, Paid Time Off, Family and Medical Leaves of Absence, and Paid Parental Leave
• Commuting Benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• Childcare Benefits

Pay

The estimated base salary for this position is $96,000- $132, 000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

Schedule

Baxter has a flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.