Principal Eng, Disposables

Vantive; Bengaluru; On-site; INR 1,400,000 - 2,400,000; Full time

Benefits offered by this job

Reasonable accommodations

Job summary

Vantive, a leader in vital organ therapy, seeks an experienced Verification & Validation engineer in Bengaluru to drive V&V activities for medical devices. You will design and execute tests, develop fixtures, and coordinate with R&D, manufacturing, and QA to ensure regulatory compliance and product quality.

Responsibilities include change control, test automation, and developing robust test infrastructure while supporting audits and supplier qualification.

Qualifications

• Bachelor's or Master’s in mechanical engineering or equivalent.
• 10–16 years of V&V experience on medical devices.
• Deep knowledge of design verification and validation.
• Experience with hardware testing methodologies and best practices.

Responsibilities

• Own and drive change control activities for development and sustaining projects.
• Lead R&D studies, provide manufacturing support, contribute to specs.
• Develop, improve, and troubleshoot disposable manufacturing processes.
• Lead changes via innovative testing methods and automate tests to boost quality and productivity.
• Coordinate product integration and system testing with cross-functional teams, including automated testing.
• Plan, build, and maintain test infrastructure and budgets.
• Manage multiple projects, ensuring timely delivery and stakeholder alignment.
• Lead V&V to meet safety, regulatory, and quality expectations within timelines.
• Support ISO and regulatory audits and close audit findings with corrective actions.
• Execute IQ/OQ/PQ for equipment per QMS site policies.

Skills

Mechanical engineering

V&V (verification & validation)

Test automation

Cross-functional collaboration

Education

Bachelor's/master's degree in mechanical engineering or equivalent

10–16 years in Systems & Component level Verification & Validation

Medical device design verification knowledge

Hardware testing best practices

Tools

UTM equipment

Leak testers

Torque testers

Test fixtures design drawings

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.

Education Qualification

• Bachelor\'s/master\'s degree in mechanical engineering or equivalent relevant technical degree.
• 10 to 16 years 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

• Own and drive change control activities by ensuring accountability for all technical aspects of development, sustaining projects, and design controls.
• Lead the design and execution of R&D studies, provide manufacturing support as needed, and contribute to product specifications.
• Drive the development, improvement, and troubleshooting of disposable manufacturing processes.
• Lead and implement changes through creative solutions, adapting to new product test methods and technologies while driving test automation to improve quality assurance and productivity in test deliverables.
• Partner with R&D and cross-functional teams to coordinate product integration and system testing, including automated testing.
• Plan, build, and maintain test infrastructure, including lab budget planning and management.
• Demonstrate the ability to achieve objectives and deliver multiple projects simultaneously.
• Develop and maintain effective, collaborative working relationships with internal and external stakeholders across levels and cultures.
• Lead V&V activities to meet customer requirements, safety, regulatory, and quality expectations within committed timelines.
• Support corporate, internal, ISO, and regulatory audits by ensuring adherence to Vantive QMS requirements.
• Lead audit nonconformances or findings to closure by defining and implementing appropriate corrective actions.
• Lead and execute IQ, OQ, and PQ for equipment and instruments in accordance with QMS site policies.
• Ensure lab requirements are validated, and laboratories are qualified for intended use; coordinate shared equipment usage when needed.
• Qualify vendors and add them to the approved vendor list by coordinating with the sourcing team to ensure quick turnaround.
• Be self-motivated with strong interpersonal skills and the ability to analyze and solve complex problems through innovative thinking and experience.
• Hands-on experience with mechanical equipment such as UTM, leak testers, torque testers, and other instruments or equipment would be an added advantage.
• Design and develop fixtures based on V&V needs by preparing drawings and working closely with external vendors.
• Work with global cross-functional teams to ensure completion of V&V tasks.
• Exposure to regulatory standards, medical device manufacturing processes and procedures, RF welding, and solvent bonding would be an added benefit.
• Exposure to statistical tools such as Minitab and Six Sigma methodologies for results analysis would be an added advantage.
• Lead and execute assigned testing with minimal dependency on project owners by managing timelines, providing regular result updates, and owning final report preparation, review, sign-off, and release.

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally.

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