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Nesco Resource · 1 day ago

Systems Engineer - (Biotech/Biomedical)

Tucson, AZ

Full-time

Onsite

Mid Level

$42/hr - $45/hr

4+ years exp

Nesco Resource is seeking a Systems Engineer focused on advancing cancer diagnostics through state-of-the-art testing automation. This role involves driving software product definition, including requirements, system architecture design, risk analysis, and solution implementation to meet IVD standards.

ConsultingHuman ResourcesStaffing Agency

Responsibilities

System Lifecycle Management: Apply Systems Engineering to SW product definition, requirements, risk analysis, and testing

Project Execution: Manage software requirements, risk analysis, configuration, defect management, and verification/validation

Industry and Technology Analysis: Research trends, emerging technologies, and competitive products for software differentiation

Cross-functional Collaboration: Work with R&D, Marketing, Operations, Quality, and Regulatory teams to ensure alignment

Customer-Focused Innovation: Engage with business leaders and VoC representatives to align technical solutions with customer needs

Technical Problem Solving: Analyze complex technical challenges, present solutions, and facilitate informed decision-making

Qualification

Software RequirementsRisk AnalysisRegulated Medical DeviceSystems EngineeringSoftware IntegrationConfiguration ManagementCollaborationCommunicationOrganizational Skills

Required

Experience writing SW requirements and completing risk analysis

Ability to work independently and cross-functionally with many different groups to solicit needs and complete trade off analyses

Experience in a regulated medical device industry

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

Demonstrated knowledge in software integration and testing, including requirements engineering, tradeoff analysis, risk management, configuration management, and verification/validation

Experience in a regulated environment, familiar with FDA, ISO, and other relevant diagnostic product standards

Interest in innovative technologies and understanding of the IVD competitive landscape