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Solü Technology Partners · 11 hours ago

Systems Engineer - Electro-Mechanical

Oro Valley, AZ

Contract

Onsite

Mid Level

4+ years exp

Solü Technology Partners is seeking a Systems Engineer to drive product definition and implementation for tissue diagnostics. The role focuses on advancing cancer diagnostics through automation and requires expertise in electro-mechanical systems.

Information TechnologySoftwareStaffing Agency

No H1B

Hiring Manager

Donna Johnson

Responsibilities

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

Project Execution: Manage requirements, risk analysis, and verification/validation

Industry and Technology Analysis: Research trends, emerging technologies, and competitive products' 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

Systems EngineeringElectro-mechanical devicesRequirements engineeringRisk managementVerification/ValidationRegulated medical device experienceFDA familiarityISO standards knowledgeTradeoff analysisCollaboration skillsCommunication skillsOrganizational skillsLeadership skillsStrategic mindset

Required

Experience in front-end Systems Engineering design & development deliverables around requirements, risks & architecture

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 systems and hardware integration and testing, including requirements engineering, tradeoff analysis, risk management, and verification/validation using tools like RETINA

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