Senior Systems Engineer

Job Summary

A company is looking for a Sr. Systems Engineer I to work on diverse technical projects in a fully remote setting.

Key Responsibilities

• Research, define, and write technical requirements for software components and systems
• Perform data analysis to support product and implementation decisions
• Lead root cause investigations and provide solutions for operational software issues

Required Qualifications

• 5+ years of system/software engineering experience in the Healthcare or Medical Device industry
• Understanding of basic statistics and proficiency in data analysis using Python or R
• Experience with developing technical product/software requirements
• Familiarity with FDA 21 CFR part 820 and IEC standards 62304, 14971, and 62366
• BA/BS in a science or technical field; advanced engineering degree desired