Principal Systems Engineer

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:

Our in-home Peritoneal Dialysis (PD) systems are used around the world to support patients experiencing life-threatening chronic kidney failure. Patients rely on our devices to deliver long-term, home-based management of End-Stage Renal Disease (ESRD) thereby maintaining critical kidney function while awaiting a kidney transplant. As such, Vantive is building new platforms, devices, and connected systems to make home dialysis more efficient, consistent, and intuitive for our patients.

Vantive is seeking a Principal System Engineer to support the overall technical direction of our chronic therapy products. Based on your technical skills, you will drive various portions of the product development cycle at stages ranging from feasibility through lifecycle management. Tasks may include development of design concepts/changes, product requirements management, traceability, DHF structure & maintenance, product risk management, system integration, and verification/validation of medical devices.

What you'll be doing:

• 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

• Understand clinical and user needs and apply them to product realization

• Capture inputs for requirements from various sources such as user needs, regulatory standards, human factors, quality, manufacturing, service, etc.

• Use knowledge of technology, process, and/or therapy domains to drive solutions and product design realization from a systems perspective

• Craft design concepts and research methodologies that best meet current and future customer/business needs for a product or process domain area

• Create and maintain design history file elements

• Facilitate an improved understanding of the interrelationship between requirements, risk and reliability

• Anticipate technical challenges and risk scenarios and prepare, lead, and execute mitigation strategies to ensure optimal results

• Resolve systems-related technical issues by applying problem-solving tools such as cause-and-effect diagrams, Pareto charts, etc.

• Propose and drive solutions to technical problems that are ambiguous and diverse

• Perform impact assessments on the requirements on an ongoing basis for any proposed design / material / process changes or observations from field / service / manufacturing. As needed, propose recommended mitigations with rationale.

• Influence stakeholders and cross-functional team members within the project

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

• Use various software tools and programs to complete the above responsibilities

• Teach and mentor others in life cycle management methodologies

What you’ll bring:

• Bachelor’s degree and 5+ years or more of relevant experience, or Master’s degree and 4+ years or more of relevant experience, with a degree in Electrical, Software, Mechanical, Biomedical, or a related engineering or science discipline

• Prior experience in medical device domains preferred

• Sound knowledge of systems engineering and related areas such as electromechanical and software engineering

• A track record in electromechanical system development, preferably in medical devices or other regulated products such as aerospace, automobile, or military

• Prior experience with internet-connected, software-enabled devices and/or cyber security

• Preferred working knowledge of system modeling and requirement management too