Welcome to Natus Sensory India

We are continuing to grow our business in India and are now looking to expand our team there. Be part of this exciting journey right from the start

Natus Sensory India are a leading manufacturer of medical devices and software for a range of solutions, including eight sensory nervous systems. Our mission is to improve patient outcomes in target markets through innovative screening, diagnostic and treatment solutions. We manufacture and distribute a range of medical device products used in the diagnosis of human disorders of sensory system and neural pathways.

Job Title: Design Assurance Engineer
Department: Quality & Regulatory Affairs
Reports To: Quality Assurance Manager
Location: Bangalore- Hybrid
Position 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

📌 Design Assurance Engineer (Bengaluru)
🏢 Natus
📍 Bengaluru