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.

About Vantive

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 and vital organ therapy 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.

Job Description

The Senior Engineer supports the design, development, and lifecycle management of complex disposable/Single use medical devices and sub‑systems within the Acute Therapies portfolio. The role to define & drive product testing strategy ensure robust execution across exploratory programs, new product development, sustaining engineering, Quality, compliance, and reliability initiatives. The role provides technical expertise, strategic decision‑making, and cross‑functional leadership to deliver safe, effective, innovative, and compliant solutions that meet clinical needs and business goals.

Essential Duties and Responsibilities:

• Contribute to product and subsystem development activities across exploratory, new product development, and sustaining phases.

• Support translation of user, customer, and clinical needs into design inputs and engineering requirements.

• Defines product testing strategy, protocols and conduct the necessary testing required to validate the safety and effectiveness of the design(s). Develop test plans, test protocols, and test reports for product integration testing, also develop the setup/fixtures required for the testing.

• Defines the required tasks, test plans, deliverables, and technical direction. Constructs detailed, accurate project schedules interfacing with product development, quality, regulatory, manufacturing, and other cross functional teams.·      

• Collaborate effectively across cross‑functional and cross‑site teams; adapt communication styles and support conflict resolution.

• Lead and drive problem‑solving activities using creative thinking and structured engineering tools.

• Ensure awareness and application of FDA, ISO, IEC design control processes, standards, and procedures.

• Apply lifecycle management principles including verification, validation, sustaining engineering, and engineering change management.

• Provide technical risk identification and mitigation within assigned areas of responsibility.

• Creates and maintains design documentation that includes requirements, specifications, verification reports, Bill of Materials, detailed engineering drawings, study reports and all documents that contribute to DHF of the product family.

• Contribute to technical strategy, cost awareness, and vendor interactions as appropriate.  

• Organizes and presents technical project management overviews without assistance. Oral and written communication is well planned, organized and has a clear logical flow.

• Ensures successful integration of disposables design elements into the overall system. Resolves competing constraints between interrelated functions (R&D, purchasing, manufacturing, regulatory, marketing, etc.) required to complete the engineering and design tasks.

• Provides leadership to effectively transition products to manufacturing and ensure robust products and manufacturing processes.

• Performs in-depth engineering analysis and calculations.

• Manages integration of deliverables from sub-system design teams and external partners.

 Job Requirements:

• Strong technical foundation in engineering principles (mechanics, thermodynamics, heat transfer, fluid flow, materials, Plastic technology) applied to disposable/single use medical devices.

• Knowledge of product lifecycle management, including NPD, sustaining engineering, engineering change management, value improvement projects, and quality remediation.

• Good understanding of design control and medical device regulatory frameworks (FDA, ISO, IEC) with ability to lead compliance strategy.

• Systems‑level thinking and ability to drive solutions to ambiguous, complex, multi‑disciplinary problems.

• Risk management accountability including anticipating system risks and defining mitigation strategies.

• Good communication skills, including technical storytelling, and influencing across global stakeholders.

• Innovation, driving new concepts, novel test methods, and inventive approaches to technical problems.

• Growing ability to apply business judgment related to cost, feasibility, and vendor interactions.

 Education and Experience

• Graduate or Postgraduate in Mechanical Engineering/ Polymer Technology/Plastic Technology/Bio Medical engineering or closely related field.

• Minimum 5 years of product life cycle experience.

• Prior experience of technical and project leadership in Sustenance/New product development in Medical device or other highly regulated industry

• Prior experience in Design and Development of Single use medical device is a plus.

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 click on the link here and let us know the nature of your request along with your contact information. Form Link

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 click on the link here and let us know the nature of your request along with your contact information. Form Link

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