Engineer II, Systems

Overview

Engineer II, Systems at Baxter contributes to the design and development of a product or solution, from conception through design and verification/validation, applying systems engineering and technical expertise.

What you'll do

• Define and translate customer, business, regulatory, performance, usability, and safety requirements into clear system requirements and product specifications.
• Lead requirements engineering activities, including use case development, requirements decomposition, traceability, and change management using tools such as DOORS, Polarion, or equivalent platforms.
• Apply systems engineering principles to balance design trade-offs, identify risks early, and support informed technical decision-making.
• Execute and support risk management activities in accordance with ISO 14971, ensuring product safety and regulatory compliance throughout the development lifecycle.
• Partner with cross-functional engineering teams to resolve technical challenges and drive optimal technology solutions.
• Support Usability Engineering and Human Factors activities, ensuring compliance with IEC 62366 and relevant FDA guidance.
• Apply reliability and robustness engineering principles to enhance product performance, quality, and customer experience.
• Develop high-quality technical documentation that effectively communicates system architecture, requirements, design decisions, and development outcomes.
• Collaborate closely with software, hardware, and systems teams to support successful product integration and development testing.
• Work with Verification & Validation (V&V) teams to define comprehensive verification strategies and test plans that ensure thorough requirements coverage.
• Provide technical leadership and expertise to help projects achieve key objectives related to quality, cost, schedule, and regulatory compliance.
• Champion best practices in systems engineering, risk management, and product development.

What you'll need

• Bachelor's degree in Mechanical Engineering, Electrical Engineering, Electronics Engineering, Software Engineering, Computer Science, Biomedical Engineering, Industrial Engineering, or a related technical discipline.
• 3-6 years of experience in Systems Engineering, with a strong focus on electro-mechanical product development.
• Experience supporting the development of complex products within highly regulated industries, preferably medical devices.
• Working knowledge of FDA regulations, Medical Device Regulation (MDR), and applicable quality and regulatory standards.
• Experience with requirements management, systems engineering processes, and product lifecycle development.
• Familiarity with Usability Engineering and Human Factors Engineering methodologies.
• Understanding of design and development tools and methodologies such as QFD (Quality Function Deployment), Pugh Matrix, CTQ (Critical to Quality), Design for Reliability (DFR), and Design for Excellence (DFX).
• Knowledge of FDA, ISO, and IEC standards, including design controls, risk management, and product development best practices.
• Strong analytical and problem-solving skills with the ability to evaluate complex technical challenges and recommend effective solutions.
• Proven ability to manage multiple priorities and successfully deliver project objectives within quality, cost, and schedule expectations.
• Excellent communication and interpersonal skills, with a demonstrated ability to collaborate effectively across cross-functional teams.