Engineer II, Systems

Responsibilities

• Identify and define customer needs, functions, performance, usability, and safety requirements for medical products.
• Manage requirements and decomposition of system-level requirements to modules using tools such as DOORS or POLARION.
• Execute risk management processes in accordance with EN ISO 14971 throughout the product life cycle.
• Support Usability Engineering activities to ensure compliance with IEC 62366 and FDA guidance.
• Collaborate with software and hardware engineers to support design development and integration.
• Partner with verification and validation engineers to develop test plans with comprehensive coverage.
• Complete high-quality technical documentation to capture and communicate complex designs.

Requirements

• Bachelor's Degree in Engineering (Mechanical, Electrical, Electronics, Software, Bio-Medical, Industrial) or Computer Science.
• 3 to 6 years of experience in Systems Engineering, specifically within Electro-Mechanical System Design.
• Proven experience in Medical Device development and familiarity with FDA Regulations and MDR.
• Strong understanding of FDA, ISO, and IEC design control procedures, regulations, and standards.
• Practical experience with engineering methodologies such as QFD, Pugh Matrix, CTQ, DFR, and DFX.

Preferred Qualifications

• Exposure to the Usability Engineering Process.
• Knowledge of principles regarding Reliability and Robustness in product development.
• Ability to manage multiple projects simultaneously in a fast-paced environment.

About the Company

Baxter is a global healthcare leader dedicated to the mission to Save and Sustain Lives. We redefine healthcare delivery through innovation in diagnosis and therapies, helping patients and physicians manage chronic or acute respiratory and cardiac diseases. At Baxter, we foster a culture of courage, trust, and collaboration where every individual is empowered to make a meaningful impact on patient lives.