Vantive
Website:
vantive.com
Job details:
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.
7 to 12years of relevant Experience in Systems & Component level Verification & Validation activities.
Relevant technical testing/reliability experience in Plastic/Connectors/Products/electro-mechanical.
Understanding of hardware methodologies and test best practices.
Essential Duties And Responsibilities
Own change management activities for development and sustaining projects, including technical coordination, design control documentation, change implementation, data management, lifecycle verification, and cross-functional alignment.
Plan, design, and execute R&D studies for disposables, including support for manufacturing readiness, verification and validation, and product specification updates.
Active Supports to PDO in design control activities, documentation (DHF), change implementation, data management, LCV and coordination across functions.
Lead product design verification and validation activities across multiple sites throughout the product development lifecycle.
Drive improvements in product test methods, technologies, and test automation to enhance quality, efficiency, and productivity in test deliverables.
Lead verification and validation activities to ensure customer, safety, regulatory, and quality requirements are met within committed timelines.
Lead SPO activities for PD Disposables, including label content verification, design verification, MDR support, and change control execution.
Prepare test protocols, final reports, FDRs, and DIRs, ensuring proper routing, review, sign-off, release, and closure.
Adhere to the Vantive Quality Management System and represent the function during corporate, internal, ISO, and regulatory audits.
Lead and execute IQ, OQ, and PQ activities for equipment and instruments in accordance with QMS site policies.
Hands-on experience with mechanical equipment such as UTM, leak testers, torque testers, and other relevant instruments would be an added advantage.
Design and develop fixtures to support V&V needs by preparing drawings and working closely with external vendors.
Experience in medical device product development, design verification and validation, system integration, risk management, reliability engineering, process validation, and quality systems.
Plan and execute DOE activities to support technical investigations, issue resolution, and data-driven decision-making.
Collaborate with global cross-functional teams to ensure timely completion of assigned tasks and project deliverables.
Exposure to regulatory standards, medical device manufacturing processes, and procedures, including RF welding and solvent bonding, would be an added advantage.
Exposure to statistical tools such as Minitab and Six Sigma methodology for results analysis would be an added advantage.
Lead assigned testing activities with minimal dependency on owners by managing timelines, providing regular test result updates, and preparing final reports through routing, review, sign-off, release, and closure.
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
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