Principal Eng, Systems

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

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 is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

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

Reasonable Accommodation

Vantive 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. Form Link

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