Principal Risk Engineer

Responsibilities

• Lead risk management activities in accordance with ISO 14971 and corporate procedures related to 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 and/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 and other scenarios using appropriate severity and probability models and ensure risks are reduced to acceptable levels or provide decision support to management or post-market monitoring.
• Update risk management files based on design changes and post-market information and ensure 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 (Biomedical, Mechanical, Electrical, Systems Engineering, Computer Science or related field)
• 5+ years (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, and documentation.
• Excellent analytical, problem-solving, and communication skills
• Ability to manage multiple priorities and project schedules
• 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

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. Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our 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. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change. Your role at Baxter The Risk Engineer is responsible for leading and executing risk management activities for infusion pump systems through 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 (e.g., ISO 14971) by working with engineering, quality, regulatory, clinical, manufacturing and service teams to integrate risk management into product design, development, and post-market activities in support of ongoing product safety.

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