Senior Risk Engineer

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.
• Join us in making a difference and ensuring the safety and efficacy of our life-saving technologies. Your expertise will help us deliver outstanding healthcare solutions!
• 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.
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Benefits

Additional Information

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.

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