Sharp Decisions
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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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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