System Engineer

System Engineer
Location: Hazelwood, MO | Onsite
Experience: 7+ Years
Work Arrangement: Onsite
Visa: Any Visa Except H1B

Role Overview:
We are seeking an experienced System Engineer with strong expertise in AWS, software/system engineering, product development, requirements management, and cross-functional coordination.

The ideal candidate will have experience owning system requirements, traceability, SDLC activities, and working closely with engineering, quality, regulatory, manufacturing, and other cross-functional teams.

Required Skills & Experience:

Experience creating and managing:

System Requirements Specifications (SyRS)
Product Requirements Documents (PRD)
Requirements Traceability Matrix (RTM)
Requirements traceability and Regulatory/Compliance experience
Strong cross-functional collaboration and coordination

Preferred Experience
Experience in regulated industries, especially medical devices
AWS cloud-based product development
Experience working with Hardware, Software, and Systems R&D
Collaboration with QA, Regulatory Affairs, Manufacturing, and Supply Chain
Experience coordinating onsite and offshore delivery teams
Experience leading design reviews and issue resolution

Nice to Have
HTML5, CSS, JavaScript
Bitbucket Pipelines
Windows Shell scripting
Experience working with clinical and marketing teams
FDA / medical-device processes

Key Responsibilities
Support product development and SDLC activities
Define and maintain system and product requirements
Ensure requirements traceability through RTM
Support regulatory and compliance activities
Drive issue resolution and participate in design reviews and decision-making
Collaborate with R&D, QA, Regulatory Affairs, Manufacturing, Supply Chain, Clinical, and Marketing teams
Act as the primary interface between onsite customer teams and offshore delivery teams

Education
Bachelor’s or Master’s degree in Computer Science, Software Engineering, Systems Engineering, Electrical Engineering, or a related field
7+ years of relevant professional experience