Sr. Systems Engineer

Vantive; Plymouth (MN); On-site; USD 88,000 - 121,000; Full time

Benefits offered by this job

Onsite work policy (3 days/wk)

Flexible Spending Accounts

Educational assistance

Paid time off (20–35 days)

Parental leave

Employee discounts

EAP

Childcare benefits

Job summary

Vantive, a vital organ therapy company, is seeking a Senior System Engineer to steer the technical direction of chronic therapy products. Based in Minnesota, you will drive requirements, design concepts, risk management and system verification across the lifecycle.

Collaborating with global cross‑functional teams, you will tackle complex problems, maintain design history files, and ensure robust, patient‑focused solutions.

Qualifications

• Bachelor's degree with 3+ years of relevant engineering experience.
• Experience in medical devices is preferred.
• Knowledge of systems engineering and related areas.
• Familiar with risk-based analysis and root-cause analysis.
• Ability to work with global, multi-functional teams.
• Strong analytical and problem-solving skills.

Responsibilities

• Perform systems engineering across product lifecycle from development to post-market.
• Translate clinical and user needs into product requirements.
• Capture inputs from stakeholders including regulatory, quality and manufacturing.
• Develop design concepts and risk mitigation strategies.
• Maintain design history file elements and traceability.
• Assess impact of requirements on risk and reliability.
• Collaborate with cross-functional teams to drive solutions.
• Apply problem-solving tools to resolve technical issues.
• Use software tools to support design and verification activities.

Skills

Systems engineering

Electrical engineering

Software engineering

Biomedical engineering

Cyber security

Risk analysis

Root cause analysis

Cross-functional teamwork

Problem solving

Traceability

DHF management

Education

Bachelor's degree in Engineering

Job description

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 Senior 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 in scope
• Perform impact assessments on the requirements as needed with support from key stakeholders
• Collaborate with stakeholders and cross-functional team members within the project
• Use various software tools and programs to complete the above responsibilities

What you’ll bring:

• Bachelor’s degree and 3+ years or more of relevant experience, or Master’s degree and 2+ 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 devices domains preferred but not required
• Knowledge of systems engineering and related areas such as electromechanical and software engineering
• Understanding of internet-connected, software-enabled devices and/or cyber security
• Familiarity with risk-based analysis and/or root cause analysis
• Ability to work with multi-functional, global teams
• Excellent interpersonal, communication, and influencing skills
• Ability to work independently
• Ability to 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

We understand compensation is an important factor as you consider the next step in your career. At Vantive, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $88,000 to $121,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

Bar coding, Printing, & Label Specifications (Applying / Overseeing (2)), In-depth Understanding of Operational Systems (Learning / Doing (1)), Laboratory Maintenance & Material Tracking (Not Applicable (0)), Packaging Assessments (Applying / Overseeing (2)), Packaging Design (Learning / Doing (1)), Packaging Regulatory Standards & Requirements (Learning / Doing (1)), Packaging Validation (Learning / Doing (1)), Packaging Verification Study Development & Testing Standards (Applying / Overseeing (2)), Product & Medical Packaging Materials / Equipment Knowledge (Learning / Doing (1)), Test Method Execution – Technician (Learning / Doing (1))

US Benefits at Vantive

This is where your well-being matters. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

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.

Equal Employment Opportunity

Vantive is an equal opportunity employer. Vantive evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Know Your Rights: Workplace Discrimination is Illegal.

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, let us know the nature of your request along with your contact information.