Systems Engineer II

Responsibilities

• Identify and define customer needs, functions, performance, usability, and safety requirements for medical device solutions.
• 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.
• Engage with verification and validation engineers to assist in the development of test plans with comprehensive coverage.
• Complete high-quality technical documentation to capture and communicate complex designs.

Requirements

• Bachelor's Degree in Mechanical, Electrical, Electronics, Software, Biomedical, Industrial Engineering, or a related field.
• 3 to 6 years of experience in Electro-Mechanical System Design, specifically within a systems engineering function.
• Proven experience in medical device development.
• Working knowledge of FDA regulations and MDR.
• Understanding of ISO and IEC design control procedures, regulations, and standards.
• Experience with requirements management tools like DOORS or POLARION.

Preferred Qualifications

• Exposure to Usability Engineering processes.
• Experience with engineering methodologies such as QFD, Pugh Matrix, CTQ, DFR, and DFX.
• Knowledge of reliability and robustness principles in product development.

About the Company

Baxter is a global healthcare leader dedicated to a mission to save and sustain lives. We redefine healthcare delivery through innovation in diagnosis and therapies, helping patients and physicians manage chronic and acute diseases. Our culture is built on courage, trust, and collaboration, empowering every individual to make a meaningful impact on patient lives worldwide.