Job Description

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare. Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission. Summary A Systems engineering professional with experience in systems areas like Product Risk management, Product Requirements, System integration and Verification & Validation of medical devices. This position may own & perform Risk management activities for a family of dialysis devices as they are used in dialysis therapy, in accordance with the regulatory standards (main being ISO 14971). Essential Duties and Responsibilities:

• Performs the activities associated with the Risk Management of one or more products in various stages of the product lifecycle from new product development to post market surveillance.
• Performs risk assessment on an ongoing basis for any proposed design/material/process change or an observation in the field/service or manufacturing to determine the impact and need for any mitigation. Come-up with the recommended mitigation with the rationale.
• Ensure that no unacceptable risk goes undetected and unmitigated.
• Expedite, manage, and coordinate interrelated Risk Management activities across functions, within the constraints of human and financial resources and changing priorities.
• Participate in identifying and planning tasks, activities, and resourcing needs related to Risk Management.
• Facilitate an improved understanding of the interrelationship between Risk and Reliability.
• Working knowledge of FMEAs and standards applicable to Reliability Engineering.

• Provides subject matter expertise to product development teams to ensure Risk Management principles are applied throughout the development cycle.
• Leads Risk Management activities in coordination with other cross-functions like HW, SW, HF,…
• Collaborates with Engineering, Manufacturing and Service organizations in the development of design FMEA, Process FMEAs and roll-up into Risk Management files.
• Creates and approves Design History File deliverables associated with Risk Management.
• Provides ongoing risk analysis and identification of required risk mitigations to ensure safe, effective product.
• Able to analyze risk/tradeoffs and make recommendations of appropriate path forward.
• Successfully influences stakeholders and cross-functional team members within the project.
• Leverages knowledge of technology, process, and/or therapy domains to drive solutions and product design realization from a systems perspective.

Qualifications:

• Must possess sound knowledge of systems engineering disciplines and related areas like Electro-mechanical systems with software. Working knowledge of materials, fluid mechanics.
• A demonstrated track record in electromechanical system development, preferably medical devices or other highly regulated products such as military hardware
• Proven ability to create results within budget, timeline, and product/project deliverable

Education and/or Experience: An engineering graduate in Electronics, Biomedical or related engineering discipline and 10+ years of relevant experience. Prior experience in Medical/Renal device domain is a plus Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information. Recruitment Fraud Notice

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