Engineer II, Systems

What You'll Be Doing

• 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.
• Contribute to the successful delivery of innovative healthcare solutions by championing best practices in systems engineering, risk management, and product development.

What You'll Bring

• 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.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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