Job Description

Vantive: A New Company Built On Our Legacy Baxter is on a journey to separate our $5B Kidney Care segment into a standalone company. Vantive. will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don\'t settle for the mediocre. Each of us are driven to help improve patients\' lives worldwide. Join us as we revolutionize kidney care and other vital organ support. .Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions. About Baxter Baxter provides a broad portfolio of essential renal and hospital products, including home, acute, and in-center dialysis sterile IV solutions infusion systems and devices parenteral nutrition surgery products and anesthetics and pharmacy automation, software, and services. The company\'s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter\'s employees worldwide are building upon the company\'s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care. Role Summary: As Senior Principal Engineer, Systems professional will be responsible for Product Requirements management, Traceability, DHF structure & maintenance, Product Risk management, System integration, verification, and validation of medical devices. This position may own & perform relevant System Engineering activities for a family of devices in Acute therapies. Technically lead the team of system engineers towards realizing product development/enhancements over its lifecycle. Essential Duties and Responsibilities: Performs the activities associated with the Systems engineering of one or more products in various stages of the product lifecycle from new product development to post market surveillance. Gathers inputs for Requirements from various sources such as Standards, User needs, Regulatory, Quality, Human factors, Manufacturing, Service and so on. Performs impacts assessment on the requirements 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. Expedite, manage, and coordinate interrelated systems 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 systems engineering. Facilitate an improved understanding of the interrelationship between Requirements, Risk and Reliability. Working knowledge of FMEAs and standards applicable to Systems Engineering. Creates design concepts and research methodologies that best meet current and future customer & business needs for a product or process domain area. Understands clinical and user needs and is able to apply to product realization. Creates and maintains Design History File elements. 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. Thorough understanding and drives application of phases of life cycle management. Ability to apply life cycle management principles across all phases of life cycle management. Teaches and mentors others in life cycle management methodologies. Initiates, develops and leads technical feasibility analysis for products or subsystems translates customer/user needs to product needs. Proposes and drives solutions to complex technical problems that are ambiguous and diverse in scope. Drives adherence to FDA, ISO and IEC design control procedures, regulations and standards. Anticipates technical challenges and risk scenarios and prepares, leads, and executes mitigation strategies to ensure optimal results. Can perform as an independent reviewer in technical and design reviews. Qualifications and Requirements: An engineering graduate in Electrical, Mechanical, Biomedical or related engineering discipline with 12-18 years of experience. Prior experience in Medical/Acute device domain is a plus. Demonstrated ability to work with technical leadership team to implement product platform/subsystem multi-generation technology plan for a specific release of a global program/product Demonstrated broad exposure to HW/SW/Systems design and technical depth in one or more engineering disciplines (Electrical, Mechanical, Software, etc) A demonstrated track record in electromechanical system development, preferably medical devices or other highly regulated products such as military hardware. Effective communication skills, both verbal and written Demonstrated strategic technical planner and thinker with ability to drive architecture/ platform/ technology deliverables into the product roadmap to ensure competitive differentiation. 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 here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our . 121677

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