Sr. Engineer – Disposables R&D, (hybrid)

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

Job summary

Vantive seeks an engineer to support or lead development of new disposable medical devices with global cross-functional teams. You will translate user needs into precise product requirements and drive design through a stage/gate NPD process.

Responsibilities include identifying and solving engineering problems using DFSS, design controls, CAD tools (Creo/SolidWorks), and risk management per ISO 14971. You will build prototypes, run validations, and ensure regulatory compliance.

Qualifications

• BS in Mechanical/Plastics/Biomedical Engineering or related field.
• 3–5+ years in Class II/III disposables medical product development.
• DFSS training or certification preferred.
• Operating within a stage/gate based NPD process.
• Knowledge of plastics processing (injection molding, extrusion, ultrasonic welding, UV/solvent bonding, sterilization).
• CAD and PDM software (Creo, SolidWorks).
• FDA Design Controls and ISO 13485 knowledge.
• ANSI/AAMI/ISO 14971 medical device risk management knowledge.
• Takes initiative with learning, innovation and continuous improvement.
• Strong collaboration and communication skills.
• Attention to detail and ability to manage multiple priorities.
• Excellent reading/writing in English.

Responsibilities

• Support or lead projects with global cross-functional teams for disposable products development.
• Translate user needs into product requirements.
• Investigate and solve engineering problems using risk-based approaches and tools (dFMEA, HF, CAD).
• Create and maintain design history file documentation.
• Develop and execute test methods, validations, and verifications.
• Build prototypes and tooling; operate machine tools as needed.
• Adhere to design controls, safety rules, policies, FDA/ISO regulations.

Skills

DFSS training

Stage/gate NPD

CAD

PDM software

FDA Design Controls

ISO 13485

ANSI/AAMI/ISO 14971

English reading/writing

Initiative & learning

Communication skills

Attention to detail

Education

BS in Mechanical/Plastics/Biomedical Engineering

MS preferred

Tools

Creo

SolidWorks

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:

Supports new product development initiatives for disposable medical devices.

What you’ll be doing:

• Support or lead projects, with global cross-functional teams, for the development of new disposable products or product extensions.
• Develop user needs and translate them into product requirements.
• Identify, investigate, and solve engineering problems utilizing risk-based and customer focused approaches and engineering tools. (e.g. dFMEA, Human Factors Engineering, statistical software, CAD).
• Create, modify, and maintain design history file documentation including protocols, reports, design specifications, labeling, and design drawings.
• Develop and execute test method validations, product testing, and verification / validation activities.
• Build prototypes and models. May operate machine tools, design and build basic tooling, test fixtures and assembly equipment.
• Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance.

What you’ll bring:

• BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred.
• 3 – 5+ years of related experience in Class II or Class III disposables medical product development.
• Design for Six Sigma (DFSS) training or certification preferred
• Operating within a stage/gate based new product development process.
• Working knowledge of plastics materials and processing such as injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization.
• Working knowledge of CAD and PDM enterprise software (e.g. Creo, Solidworks).
• Working knowledge of FDA Design Controls and ISO 13485 Quality Management Systems.
• Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices.
• Takes initiative with a high aptitude for learning, innovation, and implementing best practices and continuous improvements.
• Strong collaboration, verbal and written communication skills.
• Strong attention to detail, organized, and able to independently manage multiple priorities.
• Ability to read, write and comprehend English

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 $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. 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

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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

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.

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Reasonable Accommodation

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