System Engineer

Job Title: Systems Engineer Integration

Location: Tucson, AZ 85755 (100% On-site)

Employment Type: 11 Month Contract with possibilities for extensions (W2 | Full-Time)

Pay Rate: $42.00 – $45.00 per hour (depending on experience)

Role Overview

BEPC is seeking an experienced Systems Engineer – Integration to support research and development initiatives for advanced diagnostic systems. This role focuses on requirements engineering, system integration, risk management, and verification & validation activities within a regulated IVD environment.

The ideal candidate brings strong systems engineering fundamentals, experience working in regulated product development, and the ability to collaborate across cross-functional engineering, quality, and regulatory teams.

Key Responsibilities

System Lifecycle & Integration

• Apply systems engineering principles across the system lifecycle with emphasis on:
• Requirements engineering
• Risk management
• Verification and validation (V&V)
• Define system architectures and integration strategies to meet regulatory and performance requirements
• Execute configuration management, defect management, and V&V activities using company-standard tools

Requirements, Risk & Validation

• Develop, analyze, and manage complex system requirements with full traceability
• Perform risk analysis and mitigation activities (e.g., FMEA)
• Define and support robust verification and validation strategies aligned with regulatory standards
• Identify tradeoffs and guide technical decision-making with data-driven recommendations

Cross-Functional Collaboration

• Partner closely with R&D, Quality, Regulatory, Operations, and Marketing teams
• Facilitate stakeholder discussions to prioritize requirements, assess risks, and define validation criteria
• Ensure alignment with organizational objectives and regulatory expectations

Technical Problem Solving

• Investigate complex technical challenges and present multiple solution paths
• Support system robustness through troubleshooting, analysis, and continuous improvement
• Analyze industry trends, emerging technologies, and competitive products to inform system requirements and risk strategies

Qualifications Required:

• Bachelor’s degree in Engineering, Biomedical Sciences, or a related technical field with 4 years of experience

OR Master’s degree with 2 years of experience

OR PhD

• Demonstrated experience in systems engineering, including:
• Requirements engineering
• Tradeoff analysis
• Risk management
• Configuration management
• Verification & validation
• Experience working in regulated environments (FDA, ISO, or similar standards)
• Strong analytical, problem-solving, and documentation skills
• Excellent written and verbal communication skills
• Ability to manage multiple priorities and complex projects

Preferred:

• Deep experience with:
• Requirements elicitation and management
• Risk analysis methodologies (e.g., FMEA)
• Usability engineering
• V&V test strategy development
• Familiarity with assay development processes
• Experience with RETINA (Requirements & Test Integration Application)
• Experience using LucidSpark or LucidChart
• Advanced understanding of:
• Software engineering
• Electronics and electromechanical systems
• Information technology
• Basic chemistry
• Strong leadership presence and ability to facilitate complex technical discussions

Work Environment

• 100% on-site R&D and engineering environment
• Highly collaborative, cross-functional team setting
• Fast-paced, regulated product development environment
• Focus on innovation, quality, and patient impact