Principal Engineer, Acute Disposables (Hybrid)

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. 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 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: Leads team in defining project strategies, developing goals, and ensures project scope is defined and controlled Continuously interacts with all functions and levels of management ensuring effective ongoing communications across teams and stakeholders Ensures identification and communication of project risks, development of risk plan and proactive management of risk response strategies Anticipates potential conflict situations for proactive solutions and manages conflict situations to result in win-win outcomes Ability to communicate effectively using a wide variety of skills and means of presentation Ability to manage cross-functional teams simultaneously in a matrix environment Thorough understanding and drives application of phases of life cycle management Ability to apply life cycle management principles within exploratory, new product development or sustaining phases Demonstrates understanding of and adherence to FDA, ISO and IEC design control procedures, regulations and standards within area of responsibility/expertise 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. Ensures successful integration of disposables design elements into the overall system. Resolves competing constraints between interrelated functions (RD, purchasing, manufacturing, regulatory, marketing, medical.,) required to complete the engineering and design tasks. Leads troubleshooting and problem-solving efforts of the products associated with field performance and manufacturing. Ensures Systems that are optimized for production, reliability, regulatory compliance, and cost. Provides leadership to effectively transition products to manufacturing and ensure robust products and manufacturing processes. Manages integration of deliverables from sub-system design teams and external partners. Education and Experience Graduate or Postgraduate in Mechanical Engineering/ Polymer Technology/Plastic Technology/Bio Medical engineering or Equivalent. 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 .