Job Description & Details
This is a serious, high-stakes verification and validation gig where your bugs actually matter because they impact physical medical hardware and scientific instruments. If you hate dry documentation and strictly regulated environments, keep walking; but if you enjoy the rigor of shipping life-critical software under FDA oversight, this is a solid place to make an impact.
What You'll Actually Be Doing
You are going to spend your days knee-deep in hardware-software integration testing, making sure the code behaves correctly when it directly drives physical components. You will author and execute validation plans, navigate strict ISO 13485 processes, and lead the charge on cybersecurity risk mitigations. Expect to spend a decent amount of time aligning your verification sprints with agile development cycles while mentoring junior testers who are still learning the ropes of regulated environments.
The Core Tech Stack
You need deep hands-on expertise in testing deeply embedded systems and working within enterprise ALM platforms like Azure DevOps. The non-negotiable anchor here is your domain knowledge: commercial experience shipping medical devices or scientific instruments under strict regulatory frameworks. If you haven't dealt with FDA cybersecurity requirements or ISO 13485 compliance before, you are going to hit a wall very quickly.
Interview Expectations
Expect the hiring manager to throw a scenario at you about a hardware anomaly discovered late in the verification cycle just before an FDA submission, asking how you balance regulatory compliance speed with thorough root-cause analysis. They want to see if you panic under audit pressure or if you can methodically justify your software validation decisions. You should also be ready to explain how you integrate test case writing into fast-moving Agile sprints without cutting corners on traceability.
Application Advice
Do not just list every testing tool you have ever touched; your resume needs to scream regulatory compliance and hardware integration. Make sure keywords like ISO 13485, Azure DevOps, FDA cybersecurity, and embedded V&V are prominently featured in your experience section to clear the ATS. Highlight specific instances where you took ownership of validation plans and successfully shipped a physical product to market.