Senior Risk Engineer Job at Baxter (Round Lake)

Job Description

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.

Job Responsibility

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
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
time-off benefits such as 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

Baxter - All Job Offers

Select Country

Senior Risk Engineer

Job Description

Job Responsibility

Requirements

What we offer

Looking for more opportunities?

Senior Risk Engineer

Senior Commodities Risk Engineer

Senior Engineering Manager - Risk

Risk Analysis Credit Risk Senior Analyst

Senior Fire Engineer

Technical Safety / Loss Prevention – Senior Engineer

Intermediate / Senior Software Engineer Scientific Engine (Python)

Senior Cost Engineer

Senior Chemical Engineer

Our AI answers in your language