Eng II & Sr Eng Disposables

Vantive Healthcare Technologies; Bengaluru; On-site; INR 1,500,000 - 3,000,000; Full time

Job summary

Vantive Healthcare Technologies in Bengaluru is seeking a mechanical engineering professional with 5–10 years of experience in system and component level verification & validation. You will lead product design verification across multiple sites, drive test automation, and ensure compliance with GDP, GMP and regulatory requirements.

The role requires hands-on experience with mechanical testing equipment and strong collaboration with global cross-functional teams to deliver reliable medical

Qualifications

• Degree in mechanical engineering or equivalent tech degree.
• 5–10 years of experience in systems and component level V&V.
• Testing/reliability experience in plastic/connectors/products/electro‑mechanical.
• Understanding of hardware methodologies and test best practices.

Responsibilities

• Lead product design verification and validation across multiple sites throughout the product development lifecycle.
• Drive test automation to enhance quality and productivity in test deliverables.
• Execute V&V activities to meet customer requirements, safety, regulatory and quality needs on schedule.
• Manage SPO activities like Label content verification, design verifications, MDR & Change Control for PD disposables.
• Write testing protocols with minimal guidance following GDP and GMP.
• Adhere to Vantive Quality Management system and participate in audits (corporate, internal, ISO, regulatory).
• Execute IQ, OQ and PQ for equipment and instruments per QMS site policies.
• Hands-on experience with mechanical equipment (UTM, leak tester, torquer tester) is advantageous.
• Design and develop fixtures with external vendors per V&V needs.
• Experience in medical device product development, design verification/validation, risk management, reliability engineering, process validation and quality systems.
• Plan and run DOE to resolve technical issues during discussions and support.
• Collaborate with cross functional teams globally to complete tasks.
• Exposure to regulatory standards and manufacturing processes for medical devices is beneficial.
• Exposure to statistical tools like Minitab and Six Sigma for results analysis is a plus.
• Execute all assigned tests with minimal dependency on owners and prepare final reports.

Skills

Mechanical engineering

V&V

Hardware test methods

Test automation

Education

Bachelor's/Master's in mechanical engineering

Tools

Minitab

Six Sigma

Job description

Role & responsibilities

• 1. Bachelors/master’s degree in mechanical engineering, or equivalent relevant technical degree.
• 2. 5 to 10years of relevant Experience in Systems & Component level Verification & Validation activities.
• 3. Relevant technical testing/reliability experience in Plastic/Connectors/Products/electro-mechanical.
• 4. Understanding of hardware methodologies and test best practices.

Essential Duties and Responsibilities

• 1. Accountable for Leading product design verification and validation activities across multiple sites across the product development lifecycle.
• 2. 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. Execute V&V activities to ensure meeting customer requirements, safety, regulatory and quality needs at a committed timeline.
• 4. Execute SPO activities like Label content verification, Design verifications, MDR & Change Control activities for PD Disposables.
• 5. Ability to write testing protocols independently with minimum guidance by adhering to GDP and GMP is must.
• 6. Adheres to Vantive Quality Management system and Represents in Corporate audits, Internal audits, ISO audits and Regulatory audits.
• 7. 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 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.