Sr Eng, Codes and Standards

This is where  your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride.

A Systems engineering professional with experience in product systems architecture and systems level design, product requirements management, Traceability, DHF structure & maintenance, Compliance management, plans, requirements & testing, Product Risk management, System level integration and Validation of medical devices. This position may own & perform relevant Systems activities for the PSS and GSS products. What you’ll be doing Responsible for the coordination and development of the product systems architecture and systems level design, including the decomposition of the system architecture and requirements into subsystem and interface specifications. 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. Understands clinical and user need and can apply to product realization.  Creates and maintains Design History File elements. Leverages knowledge of technology, process, and/or therapy domains to drive solutions and product design realization from a systems perspective. Drives adherence to FDA, ISO and IEC design control procedures, regulations and standards. Can perform as an independent reviewer in technical and design reviews. Interact with clinical and marketing to develop and refine user requirements. Communicate design requirements and provide technical guidance to suppliers as needed. Ensure user needs are captured, quality requirements are met and technical risks are mitigated. Manage integration of deliverables from sub-system design teams and external partners. Identify and define high level requirements for a product or a feature that enhance the quality of therapy Identify and define high level requirements for a product or a feature that enhance the quality of therapy Plan and execute system integration activities to minimize issues in systems validation. Develop test plans, test protocols, and test reports for product integration testing. Document traceability from requirements to verification activities, and from requirements to design entities. Resolve systems-related technical issues by applying problem solving tools such as cause-and-effect diagrams, Pareto charts, etc. Develop and maintain an effective and corroborative working relationship with internal and external development partners. Develop System requirements; propose architectures and connectivity specifications of medical devices with each other and with external medical systems. Ensure appropriate traceability between requirements, interface specifications, design and verification deliverables. As Compliance Engineer: Coordination and management of standards compliance activities for assigned