Description

You will ensure design controls and risk management for new Class-II medical devices from concept to commercialization, collaborating with R&D, PMO, and manufacturing to embed quality in every phase. Your work will directly impact kidney stone treatment innovation.

Requirements

• Bachelor’s in Engineering or related technical field
• 10+ years of quality engineering experience in medical device industry
• Strong knowledge of ISO 13485, ISO 14971, IEC 62304, FDA 21 CFR Part 820
• Detailed understanding of design controls and risk management for medical device development
• Experience with design verification and validation activities

Responsibilities

• Ensure design controls compliance with FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 60601
• Drive risk management activities including FMEAs and risk-benefit analysis per ISO 14971
• Collaborate with cross-functional teams to integrate quality into product development lifecycle
• Support regulatory submissions (510(k), CE Mark) with design assurance documentation
• Lead root cause investigations and corrective actions for design-related issues