Senior Engineer, Design Assurance

Job Summary

The Senior Engineer, Design Assurance is responsible for providing critical quality engineering support throughout the product lifecycle, ensuring medical device designs remain safe, effective, compliant, and aligned with user needs and business objectives. This role partners cross-functionally with engineering, regulatory, clinical, and manufacturing teams to evaluate design changes, manage product risks, maintain design integrity, and ensure continued compliance with applicable regulatory and quality system requirements. The ideal candidate possesses a strong foundation in design controls, risk management, validation principles, and post-market quality practices, and thrives in a highly collaborative environment focused on continuous product improvement and patient safety.

This position reports to the Associate Manager, Quality and is part of the Quality Assurance team located in Bengaluru, India and will be an on-site role.

Responsibilities

• Manage and maintain the Design History File (DHF).
• Perform routine DHF audits to ensure continuous compliance.
• Review and approve design requirements (PDR/Requirements Matrix) and design changes (Change Orders) to ensure appropriate validation and verification (V&V) requirements are met.
• Collaborate cross-functionally to create and maintain risk management files and documents.
• Ensure all risk assessments are updated concurrently with design changes.
• Review and approve Test Method Validation (TMV) protocols and reports (e.g., Gage R&R) to ensure measurement systems are reliable prior to V&V execution.
• Monitor post-market feedback for early-stage products to ensure stable field performance, generating PMS Reports and Field Feedback Reviews.

Requirements

• 3+ years of experience in Quality Engineering within the medical device industry, specifically supporting Design Quality.
• Strong working knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971 requirements.
• Strong ability to read and interpret complex engineering drawings, including a solid understanding of Geometric Dimensioning and Tolerancing (GD&T).
• Proven experience generating and maintaining DHF documentation, risk management documents (DFMEA/UFMEA), and PFMEAs.
• Experience reviewing V&V protocols and Test Method Validations (TMV / Gage R&R).
• Experience investigating NCRs and performing root cause analysis.
• Proficiency with Microsoft Office applications.
• Strong communication, documentation, problem solving and leadership/management skills.
• Ability to occasionally travel internationally.

Qualifications

• Six Sigma Green Belt Certification;
• Certified Quality Engineer (CQE);
• Bachelor's Degree (B.E.) in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related technical field.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.