Sr 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.

• *About Vantive**

Vantive 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. Vantive’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**

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 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 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.

• 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 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

• *Recruitment Fraud Notice**

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