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Nesco Resource · 3 days ago

Systems Engineer - Integration

Tucson, AZ

Full-time

Onsite

Mid Level

4+ years exp

Nesco Resource is focused on advancing science and ensuring access to healthcare. They are seeking a Systems Engineer to drive requirements definition, risk management, and verification & validation practices in projects related to cancer diagnostics.

ConsultingHuman ResourcesStaffing Agency

Responsibilities

System Lifecycle Management: Apply broad knowledge and skill-sets from Systems Engineering, focusing on the requirements engineering, risk management, and verification & validation stages of the system lifecycle

Industry and Technology Analysis: Research and analyze industry trends, emerging technologies, and competitive products to identify opportunities for robust requirements, proactive risk mitigation, and effective validation strategies

Cross-functional Collaboration: Work closely with R&D, Marketing, Operations, Quality, and Regulatory teams to ensure alignment with organizational objectives and regulatory requirements, particularly regarding traceability, risk, and validation

Customer-Focused Innovation: Engage with business leaders and VoC representatives to ensure technical solutions align with customer needs and market demands, facilitating stakeholder discussions to prioritize requirements, assess associated risks, and define appropriate validation criteria

Technical Problem Solving: Analyze complex technical challenges, present multiple solution paths, and help stakeholders make informed decisions; provide innovative and clear options to address requirements definition, risk mitigation, and verification & validation challenges

Project Execution: Execute project deliverables specific to requirements engineering, risk analysis, configuration management, defect management, and verification & validation in the company-specific tool

Qualification

Systems EngineeringRequirements EngineeringRisk ManagementVerification & ValidationRegulatory StandardsTechnical Problem SolvingProject ExecutionAssay DevelopmentTechnical ToolsAdvanced KnowledgeLeadershipCommunicationOrganizational Skills

Required

Bachelor's degree in Engineering, Biomedical Sciences, or related technical field with 4 years of experience (or a Master's degree with 2 years of experience, or a PhD)

Demonstrated knowledge of systems engineering principles, specifically in 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, especially regarding requirements, risk, and validation

Demonstrated interest in innovative technologies and understanding of the competitive landscape in IVD, with an eye for potential risks, critical requirements, and robust validation approaches

Preferred

Deep knowledge in requirements elicitation, risk analysis methodologies (e.g., FMEA), usability engineering, and V&V test strategy development

Proven ability to build authority and accountability within a team, with strong collaboration and communication skills, particularly in facilitating discussions around complex requirements, risks, and validation plans

Excellent organizational skills, with the ability to efficiently evaluate, prioritize, and handle multiple projects and priorities; capability to formulate and solve problems, and complete work in a timely, accurate, and thorough manner, especially in managing extensive requirement sets, risk registers, and verification & validation matrices

Familiarity with the assay development process and its associated requirements, risks, and validation needs

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

Advanced understanding of software engineering, electronics, electro-mechanical systems, information technology, and basic chemistry, to better define requirements, assess risks, and plan validation across system components