Software Quality Engineer

Insight Global’s Med Tech Client is looking for a Software Quality Engineer to lead quality activities throughout the SDLC for Software as a Medical Device. This person would be responsible for formalizing a validation plan, testing and executing validation strategy, and providing documentation that shows the impact to the product. The Software Engineer will be working across several tools, applications and software to understand what is tied to the product to understand the impact as the company is going through a divestiture. This person should understand the appropriate level of validation needed, understand pass/fail requirements, risk management and have strong problem solving skills. Experience in Cybersecurity would be a plus. The Software Quality Engineer should also be familiar with IEC 62304.

Experience within the SDLC -

Understand software risks, from quality, understand what testing you need to do, and background to understand when to escalate, how do we document certain things, work through challenges

Software as a medical device

Experience with IEC 62304 Cybersecurity experience