Sr. Principal Engineer, 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.

Your Role:

In this role, you will be responsible for Product Requirements management, Traceability, DHF structure & maintenance, Product Risk management, System integration, verification, and validation of medical devices. This position may own & perform relevant System Engineering activities for a family of devices in Acute therapies. Technically lead the team of system engineers towards realizing product development/enhancements over its lifecycle.

What you'll be doing:

• 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, User needs, Regulatory Standards, Quality, Human factors, Manufacturing, Service, and so on. Performs impact 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. Develop the recommended mitigation strategy with a 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 can apply to product realization.  Creates and maintains Design History File elements.

• Successfully influences stakeholders and cross-functional team members within the project.

• Teaches and mentors others in life cycle management methodologies.

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

• Proposes and drives solutions to complex technical problems that are ambiguous and diverse in scope.

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

• Anticipates technical challenges and risk scenarios and prepares, leads, and executes mitigation strategies to ensure optimal results.

• Can perform as an independent reviewer in technical and design reviews.

What you'll bring:

• An engineering graduate in Electrical, Mechanical, Biomedical, or related engineering discipline

• 12-18 years of experience required

• 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 in 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.

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