Engineer I

Vantive; Plymouth (MN); Hybrid; USD 76,000 - 104,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401(k) retirement plan

Paid time off 20–35 days

Flexible spending accounts

Parental leave

Job summary

Vantive is seeking a System Engineer to guide the technical direction of Acute Therapies products. You will drive design concepts, requirements, risk, verification and validation across lifecycle stages, from feasibility to post‑market support.

The role emphasizes cross‑functional collaboration with clinicians, manufacturing and service teams, ensuring compliant, reliable medical devices.

Qualifications

• Degree in Electrical, Software, Mechanical or Biomedical engineering or related field.
• Experience in medical devices, ICU or kidney care domains preferred.
• Familiar with regulatory design controls (FDA/ISO/IEC).
• Experience in electro‑mechanical and software engineering.

Responsibilities

• Perform systems engineering across product lifecycle from development to post‑market.
• Translate clinical and user needs into product requirements.
• Capture inputs from user needs, standards, quality, manufacturing.
• Drive risk management, design verification and validation.
• Create DHF elements and maintain traceability.
• Ensure adherence to FDA/ISO/IEC design controls.
• Collaborate with cross‑functional teams and stakeholders.

Skills

Interpersonal skills

Communication skills

Influence

Independent work

Creative problem solving

Team collaboration

Education

Bachelor’s or Master’s degree in Engineering or related field

Tools

Requirement management tools

DOE

Statistical analysis tools

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 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 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.

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 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

What you'll bring:

• Bachelor’s or Master’s degree in Electrical, Software, Mechanical, Biomedical, or a related engineering or science discipline
• Prior experience in medical devices, preferably for intensive care unit (ICU) or kidney care domains
• Prior experience of systems engineering and related areas such as electro‑mechanical and software engineering
• Prior experience in electro‑mechanical system development, preferably in medical devices or other regulated products such as aerospace, automobile, or military
• Working knowledge of requirement management tools
• Familiar with statistical methods/tools for design and verification, e.g. DOE, sample size
• Excellent interpersonal, communication, and influencing skills
• Ability to work independently
• 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

Vantive is committed to supporting the need for flexibility in the workplace. 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 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 $76,000 to $104,000 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. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

Advanced Molding and Extrusion techniques (Learning / Doing (1)), Automation, reliability & smart manufacturing (Learning / Doing (1)), Critical Systems (Learning / Doing (1)), Data Analysis & Analytics (Applying / Overseeing (2)), Digitalization & Systems Engineering (Learning / Doing (1)), First Principles Thinking (Applying / Overseeing (2)), Lean & six sigma process knowledge (Applying / Overseeing (2)), Machine Learning & Artificial Intelligence (Not Applicable (0)), Manufacturing & Process Knowledge (Applying / Overseeing (2)), Modeling & Simulation (Leading / Driving (4)), Operational Quality Assurance (Learning / Doing (1)), Process Automation (Applying / Overseeing (2)), Product / Project Management (Applying / Overseeing (2)), Smart Operations / Industry 4.0 (Learning / Doing (1)), Software Integration (API, Data Pipelines) (Not Applicable (0))

US Benefits at Vantive

• 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.

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

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