System Engineer I

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

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.

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.

Experience working in a regulated environment with familiarity with FDA, ISO, and other relevant regulatory standards for diagnostics products.

Interest in innovative technologies and understanding of the competitive landscape in IVD.

Deep knowledge in software reliability, manufacturability, and usability.

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

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

Familiarity with the assay development process.

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

Job Details

Entry level

Contract

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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