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Avispa Technology

Systems Engineer - Software

Avispa Technology, Tucson, Arizona, United States, 85718

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Systems Engineer – Software

Hourly pay:

$40-$45/hr

Worksite: Leading biotechnology company (Tucson, AZ 85755 – Onsite)

W2 Employment,

Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL

40 hours/week, 11 Month Assignment

A leading biotechnology company is seeking a

Systems Engineer - Software . The successful candidate will drive software product definition, including requirements, system architecture design, risk analysis, and solution implementation to meet IVD standards.

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.

Qualifications:

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.

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

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