Systems Engineer - Test Integration & RequirementsJobs via Dice • Tucson, AZ, US
Systems Engineer - Test Integration & Requirements
Jobs via Dice • Tucson, AZ, US
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job_description.job_card.job_descriptionBachelor'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. Contract Tucson, AZ
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.
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J-18808-Ljbffr
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System Test Engineer • Tucson, AZ, US