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.

Vantive: A New Company Built on Our Legacy

Since last year, Baxter has been on a journey to separate our Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. 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 are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

JOB TITLE: Senior Engineer, Systems (Risk management)

JOB LOCATION: Whitefield, Bengaluru

Summary:

The Senior Systems Engineer will apply deep experience in developing electromechanical systems and lead risk management to drive optimal system and product level design, integration, and realization for both new product development and the sustenance of existing dialysis therapy platforms. In this role, you will be part of the Systems Engineering function within the broader R&D organization, collaborating closely with cross‑functional teams including Software, Hardware, V&V, and Digital Engineering, as well as global stakeholders in QA, RA, Clinical, Service, and Manufacturing.

The ideal candidate brings strong technical depth, systems thinking ability, and a proactive problem‑solving mindset. You demonstrate passion for innovation, excitement and energy for product development, and a passion for their work and the impact it has on extending lives and expanding possibilities.

Essential Duties and Responsibilities:

• Lead risk management to ensure requirements address identified hazards, mitigations, and residual risk acceptance.

• Lead in FMEA/FMECA activities and ensure results flow into requirements and verification.

• Actively participate in development, structuring, and decomposition of requirements for an electromechanical medical device development project.

• Participate in defining and refining user needs, use cases, and product claims.

• Translate system-level needs into functional, performance, interface, and safety requirements across mechanical, electrical, embedded, controls, and software domains.

• Ensure full bidirectional traceability using any requirement management tool, linking requirements to risk controls, architecture, design elements, and verification methods.

• Facilitate cross-functional requirement reviews, ensuring clarity, feasibility, and compliance with relevant medical standards (ISO 13485, ISO 14971, IEC 60601, IEC 62304).

• Maintain configuration control, change management, and version governance of DHF artifacts.

• Support verification planning and coverage analysis ensuring every requirement is testable and aligned with risk and design outputs.

• Collaborate with mechanical, electrical, software, controls, and quality engineering teams to ensure the architecture aligns with requirements.

• Support system-level design documentation (architecture diagrams, interface control documents, hazard analyses, robust requirements).

• Facilitate decision-making, ensuring traceable and documented rationale.

• Ensure all requirements and traceability deliverables meet medical device regulatory expectations.

• Support internal and external audits by presenting requirements, rationale, and traceability artifacts.

• Maintain high documentation quality aligned with design control requirements (21 CFR 820.30, ISO 13485).

Desirable:

Awareness of medical devices ISO and IEC design control procedures, regulations and standards.

Qualifications: 

• Bachelor’s or higher engineering degree in Electrical/Electronics, Mechanical or related discipline.

• 8-10 years of experience as a systems engineer, PRMO or a similar role.

• Proficiency in relevant software & systems, tools, & techniques.

• Strong analytical and problem-solving skills.

• A demonstrated track record in electromechanical system development, preferably medical devices or other highly regulated products.

• Excellent communication and coordination skills

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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