This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Senior Engineer, Design Assurance based in India.

Join a quality-focused engineering team dedicated to advancing medical technology and improving patient safety. As a Senior Engineer, Design Assurance, you will help ensure that medical devices remain safe, effective, reliable, and compliant throughout their lifecycle. You will work closely with engineering, regulatory, clinical, and manufacturing teams to maintain design integrity and support continuous product improvement. The role combines design quality engineering, risk management, verification and validation, and post-market performance monitoring. You will play a key role in maintaining design documentation, evaluating product changes, and ensuring compliance with industry standards. Working in a collaborative, on-site environment in Bengaluru, you will contribute to robust quality systems and dependable medical device performance.



This opportunity is ideal for an experienced quality qualified who wants to apply technical expertise to meaningful healthcare innovations.

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Accountabilities

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Manage and maintain Design History Files (DHF), ensuring documentation is complete, accurate, traceable, and compliant with applicable quality requirements.

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Conduct regular DHF audits to identify gaps, maintain documentation integrity, and support ongoing regulatory compliance.

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Review and approve design requirements, Product Design Reviews (PDR), requirements matrices, and engineering change orders, ensuring appropriate verification and validation (V&V;) activities are defined and completed.

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Collaborate with cross-functional teams to develop, review, and maintain risk management files and related documentation, including ensuring risk assessments are updated alongside design changes.

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Review and approve Test Method Validation (TMV) protocols and reports, including Gage Rep

📌 Senior Engineer, Design Assurance (India)
🏢 Jobgether
📍 India