Principal Engineer, Systems at Vantive

Bangalore, karnataka, India -

Full Time

Start Date

Immediate

Expiry Date

10 Jul, 26

Salary

0.0

Posted On

11 Apr, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Systems Engineering, Requirements Management, Electromechanical Systems, Medical Device Standards, ISO 13485, ISO 14971, IEC 60601, IEC 62304, Risk Management, FMEA, Design Control, Traceability, Embedded Software, Hardware Integration, Technical Leadership, Cross-functional Collaboration

Industry

Medical Equipment Manufacturing

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. 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: Principal Engineer, Systems JOB LOCATION: Whitefield, Bengaluru Summary: The ideal candidate will leverage his/her exposure to embedded software and its interplay with electronics/hardware to support optimal system/product level realization for new products as well as sustenance of the existing products to deliver dialysis therapy. 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 successful candidate will possess strong technical abilities, excitement and energy for product development, and a passion for their work and the impact it has on extending lives and expanding possibilities. Candidate is responsible for establishing, maintaining, and governing end‑to‑end requirements—from user needs through system, subsystem, and interface specifications—with rigorous traceability, risk alignment, and compliance with medical‑device standards. Essential Duties and Responsibilities: Lead development, structuring, and decomposition of requirements for an electromechanical medical device development projects. Work with clinical, marketing, and human‑factors teams to define and refine 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 requirement 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). Work with risk management teams to ensure requirements address identified hazards, mitigations, and residual risk acceptance. Participate in FMEA/FMECA activities and ensure results flow into requirements and verification. Support system integration builds, resolving requirement conflicts, clarifying intent, and supporting issue triage. Serve as the primary communication bridge across design engineering, quality, regulatory, service, and manufacturing teams for all requirement‑related matters. Lead technical discussions, drive alignment, and resolve requirement ambiguities or conflicts proactively. Facilitate decision-making, ensuring traceable and documented rationale. Mentor junior engineers in requirements management practices and system-thinking principles. 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. Working knowledge on dialysis equipment. Qualifications: Bachelor’s or higher engineering degree in Electrical/Electronics, Mechanical or related discipline. 10-12 years of proven experience as a systems engineer 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 Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice. At Vantive, your work will expand your skills, knowledge and opportunities for growth and learning to advance your career. In 2023, we began the journey to establish Baxter’s chronic kidney care and acute therapies businesses into one standalone company. We are thrilled to introduce you to Vantive. Together, we 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 1+ million people we serve. At Vantive, we believe in not only building our leadership in the kidney care space, but offering meaningful work to those who join us. We offer a range of exciting career opportunities across various departments, from research and development to marketing and sales. If you are looking to drive innovation and growth at a new, purpose-driven organization, we have a place for you at Vantive.

Responsibilities

Lead the development and decomposition of requirements for electromechanical medical devices while ensuring full bidirectional traceability and regulatory compliance. Facilitate cross-functional collaboration across engineering, quality, and regulatory teams to ensure system-level design integrity and risk mitigation.