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.

In the Senior Principal Engineer, Systems 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.

• Perform 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
• Gather inputs for Requirements from various sources such as, User needs, Regulatory Standards, Quality, Human factors, Manufacturing, Service, and so on. Perform 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 arationale.
• 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
• Create design concepts and research methodologies that best meet current and future customer & business needs for a product or process domain area
• Understand clinical and user needs and can apply to product realization.
  
  Create and maintains Design History File elements.
• Influence stakeholders and cross-functional team members within the project
• Teach and mentor others in life cycle management methodologies
• Initiates, develops and leads technical feasibility analysis for products or subsystems; translates customer/user needs to product needs
• Propose and drive solutions to complex technical problems that are ambiguous and diverse in scope
• Drive adherence to FDA, ISO and IEC design control procedures, regulations and standards
• Anticipate technical challenges and risk scenarios and prepares, leads, and executes mitigation strategies to ensure optimal results
• Perform as an independent reviewer in technical and design reviews

• A Bachelor's Degree in Electrical, Mechanical, Biomedical, or a related engineering or science discipline
• 12 years or more of relevant experience
• Broad exposure to HW/SW/Systems design and technical depth in one or more engineering disciplines (Electrical, Mechanical, Software, etc.)

• Prior experience in Medical/Acute device domain
• 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
• A track record in electromechanical system development, preferably in medical devices or other highly regulated products such as…