Overview
On Site
Full Time
Skills
Biomedicine
Science
Systems Engineering
System Integration
Testing
Requirements Engineering
Risk Management
Configuration Management
Verification And Validation
ISO 9000
Usability
Leadership
Accountability
Collaboration
Communication
Organizational Skills
Assays
Job Details
A client of Sharp Decisions Inc. is actively looking to bring on System Engineer to be based in AZ 85755 United States.
Educational Background : Bachelor's degree in Engineering, Biomedical Sciences, or related technical field with 4 years of experience (or a Master's degree with 2 years of experience, or a PhD).
Systems Engineering Expertise: Demonstrated knowledge of systems engineering principles, specifically in software integration and testing, including requirements engineering, tradeoff analysis, risk management, configuration management, and verification and validation.
Regulatory Familiarity: Experience working in a regulated environment, with familiarity with FDA, ISO, and other relevant regulatory standards for diagnostics products.
Strategic Mindset: Demonstrated interest in innovative technologies and understanding of the competitive landscape in IVD.
Preferred
Specialized Skills: Deep knowledge in software reliability, manufacturability, and usability.
Leadership and Communication: Proven ability to build authority and accountability within a team, with strong collaboration and communication skills.
Organizational Skills: Excellent organizational skills, with the ability to efficiently evaluate, prioritize, and handle multiple projects and priorities; capability to formulate and solve problems, and complete work in a timely, accurate, and thorough manner.
Assay Development: Familiarity with the assay development process.
Technical Tools: Prior experience in RETINA (Requirements & Test Integration Application) and with LucidSpark/LucidChart
Educational Background : Bachelor's degree in Engineering, Biomedical Sciences, or related technical field with 4 years of experience (or a Master's degree with 2 years of experience, or a PhD).
Systems Engineering Expertise: Demonstrated knowledge of systems engineering principles, specifically in software integration and testing, including requirements engineering, tradeoff analysis, risk management, configuration management, and verification and validation.
Regulatory Familiarity: Experience working in a regulated environment, with familiarity with FDA, ISO, and other relevant regulatory standards for diagnostics products.
Strategic Mindset: Demonstrated interest in innovative technologies and understanding of the competitive landscape in IVD.
Preferred
Specialized Skills: Deep knowledge in software reliability, manufacturability, and usability.
Leadership and Communication: Proven ability to build authority and accountability within a team, with strong collaboration and communication skills.
Organizational Skills: Excellent organizational skills, with the ability to efficiently evaluate, prioritize, and handle multiple projects and priorities; capability to formulate and solve problems, and complete work in a timely, accurate, and thorough manner.
Assay Development: Familiarity with the assay development process.
Technical Tools: Prior experience in RETINA (Requirements & Test Integration Application) and with LucidSpark/LucidChart
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