Systems Engineer - Lotus Project

Job Title:

Systems Engineer - Lotus Project

Job Location:

Oro Valley Arizona 85755 Job Duration: 18 months contract

Job Description:

• 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

Seeking a Systems Engineer to drive product definition, including requirements, system architecture design, risk analysis, and solution implementation to meet IVD standards. This role focuses on advancing cancer diagnostics through state-of-the‑art testing automation, providing over 250 cancer tests and associated instruments globally.

• 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.

• Educational Background:
  Bachelor's degree in Engineering, Biomedical Sciences, or related technical field with 4 years of experience (or Master's with 2 years, or PhD).
• Systems Engineering Expertise:
  Demonstrated knowledge in systems and hardware integration and testing, including requirements engineering, tradeoff analysis, risk management, and verification/validation using tools like RETINA
• Regulatory Familiarity:
  Experience in a regulated environment, familiar with FDA, ISO, and other relevant diagnostic product standards.
• Strategic Mindset:
  Interest in innovative technologies and understanding of the IVD competitive landscape.

• Specialized
  
  Skills:
  
  Deep knowledge in reliability, manufacturability, and usability.
• Leadership and Communication:
  Proven ability to build authority and accountability within a team, with strong collaboration and communication skills.
• Organizational
  
  Skills:
  
  Excellent organizational skills, capable of evaluating, prioritizing, and managing multiple projects efficiently.