Sr Eng, Systems at Vantive

Bangalore, karnataka, India -

Full Time

Start Date

Immediate

Expiry Date

15 Aug, 26

Salary

0.0

Posted On

17 May, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Project Management, Technical Communication, Requirement Gathering, Labeling Specifications, Medical Device Documentation, Vendor Management, ISO 13485, ISO 14971, IEC 62304, FDA Regulatory Standards, English Communication, Microsoft Office, Analytical Thinking, Collaboration, Prototype Fabrication, Technical Writing

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. Role Summary: Under general supervision, researches, organizes, develops and maintains, technical communication materials for Vantive products based upon internal and/or external client needs. These technical materials include, but are not limited to, operator’s manuals, service manuals, quick reference guides, configuration manuals, programming manuals, online help, and web-based documents, and applied labels Essential Duties and Responsibilities: · A strong project management exposure and ability to interact and guide team members across the globe · Ability to manage and work through various vendors to perform the labeling activities · Perform requirement gathering and analyze the requirements. · Exposure to developing labelling specifications and Labeling Detail Design documents is an added plus · Communicates effectively with subject matter experts (engineers, clinicians, etc.) to produce accurate plans · Assists with the development of plans, verification plan and reports, adheres to schedule, and ensures delivery to production · Manages and facilitates the approval and release of materials within project deadlines. · Works with external vendors to produce finished products in accordance with provided specifications. Autonomously interfaces and communicates with an international group of subject matter experts to ensure that product functionality, manufacturing, service and user issues are gathered. Qualifications and Experience: · Bachelors/ Master’s Degree or equivalent work experience. · A minimum of 8-10 years of experience with regulating bodies or the medical industry is preferred · Having exposure of working in technical publications (preferably producing medical device documentation) is an added plus. Familiarity with ISO 13485, ISO 14971, IEC 62304, FDA and other applicable regulatory standards Skills · Excellent English verbal and written communication skills. · Solid computer skills: email, documentation and collaboration tools: e.g. WebEx, Teams, Microsoft Office products, etc. · Self-directed, resourceful, and able to work on multiple projects and priorities. · Strong organization, attention to detail, and documentation skills. · Strong hands-on lab skills, and prototype fabrication skills. · Analytical, detail-oriented, thorough, and accurate. Open to accepting critiques and striving for continuous improvement in every task · A strong collaborator able to work independently and in a team · Ready to handle a broad range of tasks with multiple priorities · Focused on consistency, using style guides, branding guidelines, and company procedures to produce documentation · Clear and effective communication (written and oral) and presentation skills. · A proven track record of effectiveness in a fast-paced environment. Proven ability to create results within budget, timeline, and product/project deliverables. 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 role involves researching and developing technical communication materials, including operator and service manuals, for medical products. It also requires managing global team members and external vendors to ensure the accurate delivery of labeling and documentation.