Systems Engineer - Software

Avispa Technology•Tucson, AZ

2d•$40 - $45•Onsite

About The Position

A leading biotechnology company is seeking a Systems Engineer - Software . T he successful candidate will drive software product definition, including requirements, system architecture design, risk analysis, and solution implementation to meet IVD standards.

Requirements

4 years of experience (or Master’s with 2 years, or PhD)
Bachelor's degree in Engineering, Biomedical Sciences, or related technical field.
Experience writing SW requirements and completing risk analysis.
Experience in a regulated medical device industry.
Ability to work independently and cross-functionally with many different groups to solicit needs and complete trade-off analyses.
Systems Engineering Expertise: Demonstrated knowledge in software integration and testing, including requirements engineering, tradeoff analysis, risk management, configuration management, and verification/validation.
Regulatory Familiarity: Experience in a regulated environment, familiar with FDA, ISO, and other relevant diagnostic product standards.
Strategic Mindset: Interest in innovative technologies and understanding of the IVD competitive landscape.

Nice To Haves

Specialized Skills: Deep knowledge in software reliability, manufacturability, and usability is preferred.

Responsibilities

System Lifecycle Management: Apply Systems Engineering to SW product definition, requirements, risk analysis, and testing.
Project Execution: Manage software requirements, risk analysis, configuration, defect management, and verification/validation.
Industry and Technology Analysis: Research trends, emerging technologies, and competitive products for software differentiation.
Customer-Focused Innovation: Engage with business leaders and VoC.