Job Description

Vantive: A New Company Built On Our LegacyBaxter is on a journey to separate our ~$5B 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\xe2\x80\x99t settle for the mediocre. Each of us are driven to help improve patients\xe2\x80\x99 lives worldwide. Join us as we revolutionize kidney care and other vital organ support.*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.About BaxterBaxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company\xe2\x80\x99s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter\xe2\x80\x99s employees worldwide are building upon the company\xe2\x80\x99s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.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. 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 the R&D activities of Disposables on assigned projects.
• 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
• Can perform as an independent reviewer in technical and design reviews
• Leverage knowledge of technology, process, and/or therapy domains to drive solutions and product design realization.
• Demonstrates understanding of and adherence to FDA, ISO and IEC design control procedures, regulations and standards within area of responsibility/expertise
• Contributes to the program/project or the organization\xe2\x80\x99s technical strategy.
• Manages all technical complexities of the work, and effectively communicates with all project team members and stakeholders. This includes reporting pertinent information at key milestones.
• Responsible for preparation of project cost estimates and monitor all project expenditures and cost tracking
• 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.
• Organizes and presents technical project management overviews without assistance. Oral and written communication is well planned, organized and has a clear logical flow.
• Ensures successful integration of disposables design elements into the overall system. Resolves competing constraints between interrelated functions (R&D, purchasing, manufacturing, regulatory, marketing, etc.) required to complete the engineering and design tasks.
• Creates and maintains design documentation that includes requirements, specifications, verification reports, Bill of Materials, detailed engineering drawings, study reports and all documents that contribute to DHF of the product family.
• 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.
• Performs in-depth mechanical engineering analysis and calculations.
• Manages integration of deliverables from sub-system design teams and external partners.
• Defines protocols and conduct the necessary testing required to validate the safety and effectiveness of the design(s). Develop test plans, test protocols, and test reports for product integration testing, also develops the infra required for the testing.
• Adheres to Baxter Quality Management system and support audits and external inspections as applicable.

Education and Experience

• Graduate or Postgraduate in Mechanical Engineering / Polymer Technology / Bio Medical Engineering or Equivalent.
• Minimum 5 years of R&D experience in New product development/Sustenance.
• Prior experience of technical leadership in Sustenance/New product development in Medical device domain is a plus.
• A proven track record of management/leadership effectiveness in a fast-paced environment.
• Proven ability to create results within budget, timeline, and product/project deliverables.

A Career That MattersBaxter\xe2\x80\x99s employees are united in a mission to save and sustain lives. We are passionate about applying scientificinnovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies andtechnologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuingcreative collaborations that bring our mission to life for patients every day.Equal Employment OpportunityBaxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.Reasonable AccommodationsBaxter 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 here and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter 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 .

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