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Analyst, Product Surveillance

Not Disclosed

Job Description & Details

This is a hands-on lab gig focused on post-market surveillance for medical devices in Plymouth, MN. If you enjoy tearing down hardware, running physical tests, and documenting everything meticulously for FDA compliance, this 4-to-6-month contract is worth a look.

What You'll Actually Be Doing

You'll spend your days unboxing returned medical devices, putting them through rigorous lab testing, and figuring out why they failed in the wild. Your main job is to document every scratch, metric, and test result accurately in complaint systems. Expect to work closely with quality and engineering teams to ensure nothing slips past the regulatory cracks.

The Core Tech Stack

You don't need a heavy software background here; you need solid lab fundamentals and a degree in a technical or scientific field. Familiarity with FDA regulations, 21 CFR Part 820, and quality management systems like EPIQ will immediately set you apart. The ability to handle microscopic or tiny device components with steady hands is non-negotiable.

Interview Expectations

Expect the hiring manager to ask you about a time you had to troubleshoot a tricky physical failure while strictly following a standard operating procedure. They want to see that you won't cut corners under pressure. You'll also likely field questions about how you handle documentation errors, so be ready with a real-world example of your attention to detail.

Application Advice

Make sure your resume explicitly highlights any hands-on lab work, troubleshooting experience, or exposure to heavily regulated industries like medical devices or pharma. Don't hide your experience with documentation or quality management systems—use exact phrases from the job description like "post-market surveillance," "complaint handling," and "laboratory testing" to make sure you clear the ATS filters before Diresh looks it over.