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Systems Engineer - Test Integration & Requirements
Systems Engineer - Test Integration & RequirementsJobs via Dice • Tucson, AZ, US
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Systems Engineer - Test Integration & Requirements

Systems Engineer - Test Integration & Requirements

Jobs via Dice • Tucson, AZ, US
7 days ago
Job type
  • Full-time
Job description

Overview

Systems Engineer (Software Integration and Testing) – Location : Tucson, AZ. Length : Contract (12 Months+).

Responsibilities

  • Drive requirements definition, risk management, and verification & validation practices in projects, including defining requirements, designing system architectures, and implementing solutions to meet IVD standards.
  • Apply broad knowledge and skill-sets from Systems Engineering across the system lifecycle with emphasis on requirements engineering, risk management, and verification & validation.
  • Research and analyze industry trends, emerging technologies, and competitive products to identify opportunities for robust requirements, proactive risk mitigation, and effective validation strategies.
  • Collaborate across functions with R&D, Marketing, Operations, Quality, and Regulatory teams to ensure alignment with objectives and regulatory requirements, particularly regarding traceability, risk, and validation.
  • Engage with business leaders and Voice of Customer representatives to ensure technical solutions meet customer needs and market demands, prioritizing requirements and defining appropriate validation criteria.
  • Analyze complex technical challenges, present multiple solution paths, and facilitate informed decision-making; provide clear options for addressing requirements, risk mitigation, and validation challenges.
  • Execute project deliverables related to requirements engineering, risk analysis, configuration management, defect management, and verification & validation in the company tools.

Qualifications

  • Bachelor's degree in Engineering, Biomedical Sciences, or related technical field with 4 years of experience (or Master's with 2 years of experience, or PhD).
  • Experience in assay development at a medical device company.
  • Systems Engineering expertise : knowledge of requirements engineering, tradeoff analysis, risk management, configuration management, and verification & validation.
  • Regulatory familiarity : experience in a regulated environment with FDA, ISO, and other regulatory standards for diagnostics products, especially regarding requirements, risk, and validation.
  • Strategic mindset with interest in innovative technologies and understanding of the IVD competitive landscape, focusing on risks, critical requirements, and robust validation approaches.
  • Preferred : knowledge of Cytology assay development in clinical workflow; familiarity with cytological techniques and their applications.
  • Specialized skills : requirements elicitation, risk analysis methodologies (e.g., FMEA), usability engineering, and V&V test strategy development.
  • Leadership and communication : ability to build authority and accountability within a team with strong collaboration and communication skills, especially in facilitating discussions on complex requirements, risks, and validation plans.
  • Organizational skills : ability to prioritize and manage multiple projects; capable of solving problems and delivering timely, accurate work, especially in managing extensive requirement sets, risk registers, and verification & validation matrices.
  • Assay development familiarity : understanding of assay development processes and their requirements, risks, and validation needs.
  • Technical tools : experience with RETINA (Requirements & Test Integration Application) and LucidSpark / LucidChart.
  • Advanced knowledge of software engineering, electronics, electro-mechanical systems, IT, and basic chemistry to better define requirements, assess risks, and plan validation across components.
  • Employment type

  • Contract
  • Location

  • Tucson, AZ
  • J-18808-Ljbffr

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