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This is where new knowledge is discovered. Baxter's Research and Development teams work cross functionally to innovate, develop and introduce creative solutions for patients needs globally. From Scientists to Engineers, your work creates the products that save and sustain lives.
Job Responsibility
Translate customer needs, business objectives, and regulatory requirements into clear, testable system-level requirements
Lead and execute risk management activities in accordance with ISO 14971 (Medical Device Risk Management Standard), including: Risk management planning, Risk analysis and evaluation, Risk control implementation and verification
Decompose system-level requirements into subsystem and module-level requirements, ensuring traceability
Plan and oversee reliability and robustness activities to ensure product performance over time
Lead cross-functional teams in identifying and mitigating technical risks, resolving issues, and managing test defects
Evaluate product and design changes holistically to ensure impacts are fully assessed across system, regulatory, and business dimensions
Drive alignment across engineering, quality, and regulatory functions on system-level decisions and deliverables
Support adherence to Baxter product development processes, documentation expectations, and regulatory requirements
Requirements
Bachelor's degree in Mechanical, Electrical, Software Engineering, or a related technical discipline
5+ years of relevant engineering experience, preferably in medical devices or a regulated industry
Strong working knowledge of: ISO 14971 (Application of Risk Management to Medical Devices)