Sr Eng, Disposables

Vantive; Bengaluru; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Vantive is a vital organ therapy company focused on extending lives through digital solutions and advanced services. The role centers on leading verification and validation activities for medical device products, ensuring alignment with regulatory and quality standards across global sites.

The position requires hands-on leadership in IQ, OQ, and PQ for equipment and instruments, driving test protocols, risk management, and integration with external vendors.

Responsibilities

• Lead product design verification and validation across multiple sites.
• Drive test automation to enhance quality and productivity.
• Lead V&V to meet customer requirements, safety, regulatory and quality needs.
• Oversee design verifications, MDR & Change Control for PD and HD disposables.
• Prepare test protocols, FRs, conduct FDRs & DIRs with routing and sign-off.

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.

Essential Duties and Responsibilities:

• 1. Accountable for Leading product design verification and validation activities across multiple sites across the product development lifecycle.
• 2. 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.
• 3. Lead V&V activities to ensure meeting customer requirements, safety, regulatory and quality needs at a committed timeline.
• 4. Lead and Execute SPO activities like Label content verification, Design verifications, MDR & Change Control activities for PD and HD Disposables.
• 5. Authorize in preparing test protocols & FR’s and also conduct FDR’s & DIR’s by taking accountability and ownership with routing, review signoff and releases and driving to the closure.
• 6. Adheres to Baxter Quality Management system and Represents in Corporate audits, Internal audits, ISO audits and Regulatory audits.
• 7. Lead and Execute IQ, OQ and PQ for equipment's & Instruments as per QMS site policies.
• 8. Hands on Experience in handling Mechanical Equipment's like UTM, Leak Tester, Torquer Tester and other instrument and Equipment's would be added advantage.
• 9. Responsible for Design and Development of fixture per V&V needs by preparing drawing and working closely with external vendors.
• 10. Experience in medical device product development, design verification/validation, system integration, risk management, reliability engineering, process validation and Quality systems.
• 11. Ability to Plan & run DOE to resolve any issues to technical discussion and support.
• 12. Work with Cross Functional Teams Globally ensure completion of Cross functional tasks.
• 13. Exposure to Regulatory Standards and Manufacturing process and procedure for Medical Devices and RF welding, Solvent bonding process would be an added benefit.
• 14. Exposure to statistical tools like Minitab and Six sigma methodology for results analysis would be an added advantage.
• 15. 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.