System Engineer

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.

• 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.

• 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 Lucid Spark/Lucid Chart.

• 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.