Systems Engineer, Principal

Vantive • Plymouth, MN

14d • $108,000 - $147,000 • Hybrid

About The Position

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 PrisMax systems are used in the intensive care unit (ICU) to support patients experiencing life-threatening acute kidney injury. Clinicians rely on our devices to deliver continuous renal replacement therapy (CRRT), helping to maintain critical kidney function while patients recover. We’re building new platforms, devices, and connected systems to make therapy administration more efficient, consistent, and intuitive—so care teams can focus on the patient. Vantive is seeking a Principal System Engineer to support the overall technical direction of Acute Therapies 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, verification, and validation of medical devices.

Requirements

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

Nice To Haves

• Prior experience in medical devices, preferably for ICU or kidney care domains
• Sound knowledge of systems engineering and related areas such as electro-mechanical and software engineering
• A track record in electro-mechanical 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
• Working knowledge of system modeling language (SysML or UML) and requirement management tools
• Familiar with statistical methods/tools for design and verification, e.g. DOE, sample size
• Success in working with multi-functional, global teams
• Excellent interpersonal, communication, and influencing skills
• Ability to work independently
• Ability to manage simultaneously several projects and shift priority according to needs
• Demonstrated strong analytical and problem-solving skills
• Ability to solve problems, develop solutions, and make recommendations in collaboration with project leaders
• Creative Problem Solver – identify technical risks up front, develop and execute mitigations and provide team direction on how to remove or avoid roadblocks
• Ability to deliver results according to the plan

Responsibilities

• 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 in scope
• 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

Benefits

• US Benefits at Vantive This is where your well-being matters. Vantive offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical, dental and vision coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Aon Pooled Employer Plan (“Aon PEP”), Vantive’s 401(k) retirement savings plan, to help you prepare for your future. The Aon PEP is designed to help improve retirement outcomes by providing retirement resources more efficiently. The plan offers a robust set of investment options, financial education, and a suite of resources to support your retirement goals. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Vantive’s US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Vantive

What This Job Offers

• Job Type: Full-time
• Career Level: Principal