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.

Role Summary:

As Eng II, Systems you will be responsible for Product Requirements management, Traceability, Product Risk management support in, System integration, verification, and validation of medical devices. This position may own & perform relevant Systems Engineering 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.

• 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.

• Ability to apply life cycle management principles across all phases of life cycle management.

• Initiates, develops and leads technical feasibility analysis for products or subsystems; translates customer/user needs to product needs.

• Drives adherence to FDA, ISO and IEC design control procedures, regulations and standards.

Qualifications and Experience:

• An engineering graduate in Electrical, Mechanical, Biomedical or related engineering discipline with 3-7 years of experience. Prior experience in Medical/Acute device domain is a plus.

• 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

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