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System Engineer I
System Engineer ISharp Decisions • Tucson, AZ, US
System Engineer I

System Engineer I

Sharp Decisions • Tucson, AZ, US
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Overview

A client of Sharp Decisions Inc. is actively looking to bring on a System Engineer to be based in AZ 85755, United States.

Responsibilities and qualifications reflect a focus on systems engineering for software integration and testing within a regulated diagnostics context.

Responsibilities

  • Apply systems engineering principles across software integration and testing activities, including requirements engineering, tradeoff analysis, risk management, configuration management, and verification and validation.
  • Collaborate with cross-functional teams to ensure design and implementation meet regulatory and quality standards.

Qualifications

  • Educational Background
  • Bachelor's degree in Engineering, Biomedical Sciences, or related technical field with 4 years of experience; or Master's degree with 2 years of experience; or PhD.

  • Systems Engineering Expertise
  • Demonstrated knowledge of systems engineering principles, especially 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
  • Interest in innovative technologies and understanding of the competitive landscape in IVD.

  • Preferred Skills
  • Deep knowledge in software reliability, manufacturability, and usability.

  • Leadership and Communication
  • Ability to build authority and accountability within a team, with strong collaboration and communication skills.

  • Organizational Skills
  • Excellent at evaluating, prioritizing, and handling multiple projects; capable of solving problems and delivering accurate, timely work.

  • Assay Development
  • Familiarity with the assay development process.

  • Technical Tools
  • Prior experience with RETINA (Requirements & Test Integration Application) and with LucidSpark / LucidChart.

    Job Details

  • Seniority level
  • Entry level

  • Employment type
  • Contract

  • Job function
  • Information Technology

    Note : The description below includes job board references and related postings that are not part of the core job responsibilities. This refined description retains the essential role information and qualifications.

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