Systems Engineer

Job Title:
Systems Engineer
Location: 1910 East Innovation Park Drive, Tucson, AZ 85755
Duration: 18-month contract (with potential extension or conversion)
Pay Rate: $42 $ 45/hr (W2)
Benefits: Weekly pay, Medical, Dental, Vision

Position Overview
Tissue Diagnostics is seeking an experienced Systems Engineer to support the Lotus Project , driving product definition and system-level development for in vitro diagnostic (IVD) solutions. This role is focused on requirements engineering, system architecture, risk management, and verification and validation within a regulated medical device environment.
You will contribute to advanced cancer diagnostics platforms that support over 250 diagnostic tests and instruments used globally, working at the intersection of engineering rigor, regulatory compliance, and customer-focused innovation.

Key Responsibilities
Systems Lifecycle Execution

• Apply systems engineering principles across product definition, requirements development, system architecture, risk analysis, and testing activities.
• Ensure alignment with IVD standards and regulatory expectations throughout the product lifecycle.

Requirements, Risk & V&V Management

• Develop, analyze, and manage system requirements, risk assessments, and traceability artifacts.
• Support verification and validation planning and execution to ensure robust system performance and compliance.

Cross-Functional Collaboration

• Partner closely with R&D, Marketing, Operations, Quality, and Regulatory teams to gather inputs, evaluate tradeoffs, and drive aligned technical decisions.
• Work independently while effectively coordinating across multiple functional groups.

Industry & Technology Analysis

• Research emerging technologies, industry trends, and competitive products to support informed system-level design decisions and differentiation strategies.

Customer-Focused Problem Solving

• Engage with business leaders and Voice-of-Customer (VoC) representatives to translate customer needs into effective technical solutions.
• Analyze complex technical challenges, present solution options, and facilitate data-driven decision-making.

Required Qualifications

• Education:
  • Bachelors degree in Engineering, Biomedical Sciences, or a related technical field with 4+ years of experience
  • OR Masters degree with 2+ years of experience
  • OR PhD in a relevant discipline
• Systems Engineering Experience:
  • Proven experience in front-end systems engineering deliverables, including requirements engineering, system architecture, risk management, tradeoff analysis, and verification/validation
  • Experience with systems engineering tools such as RETINA or similar platforms
• Regulatory Environment:
  • Prior experience working in a regulated medical device or diagnostics environment
  • Familiarity with FDA, ISO, and applicable IVD standards
• Collaboration & Independence:
  • Ability to work independently while effectively engaging cross-functional stakeholders

Preferred Qualifications

• Strong background in reliability, manufacturability, and usability engineering
• Demonstrated leadership presence with the ability to establish technical authority and accountability
• Excellent organizational and prioritization skills, with the ability to manage multiple projects simultaneously
• Strong written and verbal communication skills, capable of conveying complex technical concepts clearly

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