Design Assurance Engineer

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 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 readiness activities.

Qualifications & Experience

• Education: Bachelor’s degree in Engineering (Biomedical, Mechanical, Electrical), Life Sciences, or a related technical discipline.
• Experience: Minimum of 4–5 years of quality or design assurance engineering experience specifically within the medical device industry.
• Regulatory Knowledge: Deep understanding of medical device regulations, specifically focusing on Class IIa/Class II frameworks, including ISO 13485, ISO 14971, EU MDR 2017/745, and FDA 21 CFR Part 820.
• Technical Skills: Strong experience with statistical analysis techniques (e.g., sample size determination, ANOVA, capability analysis) and risk management methodologies.
• Soft Skills: Excellent technical writing skills, a proactive problem-solving mindset, and the ability to communicate complex quality requirements clearly to technical and non-technical stakeholders.