Baxter
Healthcare
SeniorRiskEngineer
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“Senior Risk Engineer at Baxter. Skills: Risk management, Product lifecycle, Medical devices. Lead risk management activities. Follow ISO 14971”
What You'll Achieve.
Ensure patient safety; Ensure user safety; Reduce risks to acceptable levels; Ensure ongoing product safety
Industry & Context.
Analytical skills; Data-driven decision making; Risk assessment
Authorized to work in U.S.
What They're Looking For.
Must Have
Bachelor’s degree in Engineering, 3+ years medical device risk management, 3+ years product development experience, Ownership of complex systems, Ownership of complex programs, Lead risk management activities, Use FMEA, Use FTA, Use hazard analysis, Advanced proficiency with DOORS, Advanced proficiency with bug tracking systems, Advanced proficiency with end-to-end traceability, Advanced proficiency with documentation in regulated environments, Excellent analytical skills, Data-driven decision-making skills, Independently assess risk, Influence design decisions, Balance patient safety, Balance product performance, Balance compliance, Lead cross-functional teams, Influence cross-functional teams, Communicate complex risk concepts clearly, Drive alignment across stakeholders, Applicants must be authorized to work in U.S.
Nice to Have
Experience with cybersecurity risks
What You'll Do.
Lead risk management activities
Follow corporate procedures
Develop risk management plans
Perform hazard analyses
Perform fault tree analyses
Assess mechanical risks
Assess electrical risks
Assess software risks
Assess usability risks
Assess cybersecurity risks
Collaborate with cross-functional teams
Incorporate risk controls
Validate risk controls
Perform risk impact assessments
Assess change controls
Assess complaint trends
Reduce risks to acceptable levels
Update risk management files
Ensure ongoing product safety
Facilitate risk reviews
Facilitate risk management meetings
How You'll Work.
Team & Collaboration
Cross-functional teams; Engineering teams; Quality teams; Regulatory teams; Clinical teams; Manufacturing teams; Service teams
Communication Scope
Communicate complex risk concepts
Process & Methodology
Product lifecycle management
Full Job Description
**This is where** your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. ## Your Role at Baxter 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. ## What You'll Do: * 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 ris
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