Principal Engineer, Acute Disposables at Vantive

Bangalore, karnataka, India -

Full Time

Start Date

Immediate

Expiry Date

27 Jun, 26

Salary

0.0

Posted On

29 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Engineering Change Management, Root Cause Analysis, Verification & Validation, Design Transfer, Value Improvement, Regulatory Compliance, Thermodynamics, Fluid Flow, Materials Science, Plastic Technology, Product Lifecycle Management, Design Control, Risk Management, Systems Thinking, Negotiation, Innovation Leadership

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. 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 Responsible for developing solutions to challenging issues associated with the design, development, and sustenance engineering for our new and existing Disposables for the Acute Therapies product portfolio. Provide business and execution leadership for one or more projects, holding accountability for project schedule, budget, risks and interacts with all functions and levels of management ensuring effective communications. Independently drive/contribute to the Projects/Initiatives involving Engineering change management, solutions for Product quality issues, root cause analysis, NCR handling, CAPAs, verification & validation, design transfer, Value improvement programs and Regulatory compliance activities. Contribute to the development of new functions/features to be integrated into the existing products/new products. Essential Duties and Responsibilities: Lead and oversee lifecycle management across New Product Development, sustaining engineering, value improvement projects, engineering change management, and product quality remediation activities. Drive solutions to diverse technical challenges across technology, process, and therapy domains. Serve as platform technical leader (e.g., LSD, PDO) as appropriate. Translate user, customer, and clinical needs into system level, sub system and design level requirements. Champion culture levers: make timely decisions under uncertainty, cultivate innovation, manage complexity, and model effective communication tailored to diverse stakeholders. Ensure regulatory compliance by driving adherence to FDA, ISO, and other applicable design control procedures, regulations, and standards; recommend solutions to regulatory hurdles; support/participate in audit inspections and interactions with regulatory agencies/MOHs as needed. Recommend paths through complex regulatory hurdles associated with product use, performance, or safety. Foster cross‑functional and cross‑site collaboration; resolve competing constraints among inter‑related functions; build partnerships with external collaborators and suppliers as needed to meet shared objectives. Exhibit business and financial acumen by understanding cost drivers, manufacturing implications, and long‑term product profitability; make decisions with clear understanding of business impacts. Job Requirements: Technical expertise in engineering principles (mechanics, thermodynamics, heat transfer, fluid flow, materials, Plastic technology) applied to disposable/single use medical devices. Strong knowledge of product lifecycle management, including NPD, sustaining engineering, engineering change management, value improvement projects, and quality remediation. Thorough understanding of design control and medical device regulatory frameworks (FDA, ISO, IEC) with ability to lead compliance strategy. Strong systems‑level thinking and ability to drive solutions to ambiguous, complex, multi‑disciplinary problems. Risk management leadership including anticipating system risks and defining mitigation strategies. Excellent communication skills, including negotiation, technical storytelling, and influencing across global stakeholders. Innovation leadership, driving new concepts, novel test methods, and inventive approaches to technical problems. Business and financial acumen, understanding cost drivers, manufacturing implications, and long‑term product profitability. Education and Experience Graduate or Postgraduate in Mechanical Engineering/ Polymer Technology/Plastic Technology/Bio Medical engineering or closely related field. Minimum 8 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 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

The Principal Engineer is responsible for developing solutions for complex issues in the design, development, and sustenance engineering of Acute Therapies Disposables, providing leadership for projects regarding schedule, budget, and risks. This role involves driving engineering change management, quality issue resolution, root cause analysis, CAPAs, verification/validation, design transfer, and ensuring regulatory compliance across the product lifecycle.