Associate Systems Engineer

$80,000 – $100,000 · Posted 16 days ago

San DiegoLast seen 14 days ago

Summary

Associate Systems Engineer supporting the development and enhancement of in-vitro diagnostic (IVD) instruments within a regulated medical device environment. The role involves system integration testing, verification and validation (V&V) activities, troubleshooting, failure investigations, and risk assessments across multiple R&D projects. Responsibilities include executing statistical analyses, performing root cause analysis, contributing to design control documentation and regulatory submissions, and collaborating with cross-functional teams (software, hardware, assay development, quality, manufacturing). Requires a Bachelor's degree in Systems Engineering, Bioengineering, Mechanical Engineering, Electrical Engineering, or related field with 0–3 years of relevant experience; Master's preferred.

DevOps / Infrastructure Embedded Systems Bioengineering Capability Studies Corrective And Preventive Actions Data Analytics Design Control Doe Fda Iec 60601 1 In Vitro Diagnostics Iso 13485 Medical Device Development Microsoft Excel Microsoft Powerpoint Microsoft Word Regression Analysis Risk Assessment Root Cause Analysis Statistical Analysis System Modeling Systems Engineering Verification And Validation