Senior Engineer, Design Assurance

Overview

The Senior Engineer, Design Assurance provides quality engineering support throughout the medical device product lifecycle, ensuring designs remain safe, effective, compliant, and aligned with user needs and business objectives. The role partners with engineering, regulatory, clinical, and manufacturing teams and reports to the Associate Manager, Quality.

What you'll do

• 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, including 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.
• Generate PMS Reports and Field Feedback Reviews.

What you'll need

• 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.

Nice to have

• 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.

Details

• Location: Bengaluru, India.
• On-site role.
• Position is eligible for a remote work arrangement in which you can work remotely from your home.