Principal Engineer Systems
2 weeks ago
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.
Summary:
A Systems engineering professional with experience in systems areas like product requirements management, traceability, DHF structure & maintenance, product risk management, system integration and Verification & Validation of medical devices. This position may own & perform relevant systems activities for a family of devices as they are used in Acute Therapies.
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 resource 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. Leverages knowledge of technology, process, and/or therapy domains to drive solutions and product design realization in Acute Therapies. Owner of R&D program schedule creation, tracking, and execution. Responsible for delivering an integrated product with detailed plans from primary iteration to successful system verification completion. Participates as a member of cross functional teams and/or integrates cross functional inputs into project delivery. Demonstrates understanding of and adherence to FDA, ISO and IEC design control procedures, regulations, and standards. Drives Change Control Management records as Change owner and ensure timely closure. Prepares project reports, analyses and delivers presentations to R&D leadership on a weekly basis. Leads scheduled meetings in R&D, develops and manages agenda, creates minutes, and follows up action items throughout the integration steps. 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.Education and/or Experience:
An engineering graduate in Electrical, Mechanical, Biomedical or related engineering discipline with 8-12 years of experience. Prior experience in Medical/Acute device domain is a plus. Must possess sound knowledge of systems engineering disciplines and related areas like Electro-mechanical systems. A demonstrated track record in electromechanical system development, preferably medical devices or other highly regulated products such as military hardware-
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