Engineer II, Systems C&S

Responsibilities

• Contribute to the design, development, and verification of medical device products from conception through validation.
• Identify and define customer needs, performance, usability, and safety requirements while ensuring compliance with regulatory constraints.
• Execute compliance testing to ensure projects meet cost, quality, and schedule targets throughout the product life cycle.
• Manage requirements and decomposition using tools such as DOORS and Excel.
• Lead risk management processes in accordance with EN ISO 14971 to ensure product safety.
• Act as a lead integrator to proactively identify and resolve integration issues during development tests.
• Drive compliance with IEC 60601-1 and collateral standards to obtain product approvals from external safety test labs and notified bodies.
• Create and maintain technical files for MDD and STED to MDR for CE marking.
• Collaborate with QA/RA teams to register products in various geographical regions.

Requirements

• Bachelor's Degree in Mechanical, Electrical, Electronics, Software, Bio-Medical, Industrial Engineering, or a related field.
• 3 to 8 years of experience in Electro-Mechanical System Design, specifically within Codes and Standards, testing, and system engineering functions.
• Proven experience in medical device development with knowledge of FDA Regulations and MDR.
• Deep understanding of IEC 60601-1 and IEC 62304 standards.
• Proficiency in using DOORS and Excel for requirement management.

Preferred Qualifications

• Exposure to Usability Engineering processes.
• Experience with QFD, Pugh Matrix, CTQ, DFR, and DFX methodologies.
• Knowledge of EMI/EMC requirements, REACH, ROHS, and Biocompatibility.
• Strong interpersonal skills and the ability to manage multiple projects simultaneously.

About the Company

Baxter is a global healthcare leader dedicated to saving and sustaining lives. Since 1931, we have been at the forefront of medical innovation, redefining healthcare delivery to make a greater impact on patients and physicians worldwide. Our Front Line Care business unit focuses on expanding therapies for respiratory and cardiac diseases, providing essential products for airway clearance and patient monitoring.