Job Title: Design Assurance EngineerDepartment: Quality & Regulatory AffairsReports To: Quality Assurance ManagerLocation: Bangalore- HybridPosition Type: Full time

Position Summary
We are seeking an experienced Design Assurance Engineer to play a critical role in ensuring the safety, efficacy, and compliance of our portfolio of Class I & Class IIa medical devices. In this role, you will serve as the core design quality representative on cross-functional product development teams, guiding projects from concept through commercialization. You will ensure that design controls, risk management, and verification/validation activities comply with ISO 13485, EU MDR (2017/745), and US FDA 21 CFR Part 820 regulations.
Key Responsibilities

Design Controls: Lead and support cross-functional teams in the establishment, execution, and documentation of Design Controls, including design inputs, design outputs, design reviews, and design transfer.
Risk Management: Author and maintain Risk Management Files (including Hazard Analyses, dFMEAs, and pFMEAs) in strict accordance with ISO 14971,



ensuring risks are mitigated to acceptable levels.
Verification & Validation: Review and approve design verification and validation (V&V;) protocols and reports, ensuring statistical rationale and sample sizes are technically sound and compliant.
Technical Documentation: Author, review, and maintain the Design History File (DHF) and contribute directly to Technical Documentation required for CE marking under EU MDR and 510(k) submissions.
Cross-Functional Collaboration: Partner closely with R&D;, Regulatory Affairs, and Manufacturing to ensure smooth design transfer and that production processes are capable of meeting design specifications.
Change Control: Evaluate design and process changes post-launch to assess their impact on product safety, performance, and regulatory status.
Continuous Improvement: Support CAPA (Corrective and Preventive Action) investigations, root-cause analyses, and audit

📌 Design Assurance Engineer (Bengaluru)
🏢 Natus Sensory
📍 Bengaluru