Principal Eng Disposables

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.

Education Qualification

• Bachelor’s/master’s degree in mechanical engineering or equivalent relevant technical degree.
• 9 to 14years of relevant Experience in Systems & Component level Verification & Validation activities.
• Deep domain knowledge in design verification and validation of medical devices.
• Relevant technical testing/reliability experience in Plastic/Connectors/Products/electro-mechanical.
• Understanding of hardware methodologies and test best practices.
  
  

Essential Duties And Responsibilities

• Lead and Execute change through creative solutions adapting to the new product test methods and technologies and driving test automation to enhance the assured quality and productivity in test deliverables.
• Partners with R&D functionals/cross functional teams to coordinate Integration and System testing of products including automated testing.
• Plans, builds & maintains test infrastructure and manages the budget planning for the labs.
• Demonstrated experience in accomplishing objectives. Able to deliver on multiple projects simultaneously.
• Develops & maintains an effective & collaborative working relationship with internal & external stake holders across all levels & diverse cultures.
• Lead V&V activities to ensure meeting customer requirements, safety, regulatory and quality needs at a committed timeline.
• Accountable for Corporate audits, Internal audits, ISO audits and Regulatory audits by adhering to Vantive QMS.
• Lead and Drive to closure if there is an NC’s or Findings during Audits by taking necessary actions.
• Lead and Execute IQ,OQ and PQ for equipments & Instruments as per QMS site policies.
• Ensure lab requirements are validated & labs are qualified for the intended use, coordinate for common Equipment usage incase of need.
• Responsible for Qualification of Vendors & add them to approved vendors list by coordinating with sourcing team in quick turn around time.
• Must be self-motivated & have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience.
• Hands on Experience in handling Mechanical Equipments like UTM, Leak Tester, Torquer Tester and other instrument and Equipments would be added advantage.
• Responsible for Design and Development of fixture per V&V needs by preparing drawing and working closely with external vendors.
• Work with Cross Functional Teams Globally and ensure completion of Cross functional V&V tasks.
• Exposure to Regulatory Standards & Manufacturing process and procedure for Medical Devices and RF welding, Solvent bonding process would be an added benefit.
• Exposure to statistical tools like Minitab and Six sigma methodology for results analysis would be an added advantage.
• Responsible for Leading executing all assigned test with minimal dependency on owners by considering testing timelines, providing frequent updating of test results to owners, and ownership in preparing final report by routing, review signoff and releases.
  
  

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.

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