Software Quality Engineer II

Job Summary

The Software Quality Engineer II supports the development and lifecycle management of software used in medical devices by ensuring quality, compliance, and effective risk management throughout the product lifecycle. This role partners closely with Software Engineering, Systems Engineering, Regulatory Affairs, and Product Development teams to provide quality oversight from concept through commercialization.

The Software Quality Engineer II is responsible for reviewing software design and development deliverables, supporting verification and validation activities, assessing software changes, and ensuring compliance with applicable domestic and international regulations and standards. This position also contributes to continuous improvement initiatives, complaint investigations, CAPA activities, and post-market quality processes.

Success in this role requires strong knowledge of software quality principles, medical device regulations, software devel...