Systems Engineer - Integration

Systems Engineer - Integration

Tucson, AZ

8 Months

As a member of our R&D team, the Systems Engineer will drive requirements definition, risk management, and verification & validation practices in projects, including defining requirements, designing system architectures, and implementing solutions to meet IVD standards. This individual will take ownership of project deliverables and facilitate the decision‑making process with well‑considered trade‑offs.

• System Lifecycle Management:
  Apply broad knowledge and skill‑sets from Systems Engineering, focusing on the requirements engineering, risk management, and verification & validation stages of the system lifecycle.
• Industry and Technology Analysis:
  Research and analyze industry trends, emerging technologies, and competitive products to identify opportunities for robust requirements, proactive risk mitigation, and effective validation strategies.
• Cross‑functional
  
  Collaboration:
  
  Work closely with R&D, Marketing, Operations, Quality, and Regulatory teams to ensure alignment with organizational objectives and regulatory requirements, particularly regarding traceability, risk, and validation.
• Customer‑Focused Innovation:
  Engage with business leaders and VoC representatives to ensure technical solutions align with customer needs and market demands, facilitating stakeholder discussions to prioritize requirements, assess associated risks, and define appropriate validation criteria.
• Technical Problem Solving:
  Analyze complex technical challenges, present multiple solution paths, and help stakeholders make informed decisions; provide innovative and clear options to address requirements definition, risk mitigation, and verification & validation challenges.
• Project Execution:
  Execute project deliverables specific to requirements engineering, risk analysis, configuration management, defect management, and verification & validation in the company‑specific tool.

• Educational Background:
  Bachelor's degree in Engineering, Biomedical Sciences, or related technical field with 4 years of experience (or a Master's degree with 2 years of experience, or a PhD).
• Systems Engineering Expertise:
  Demonstrated knowledge of Isle in engineering principles DY, specifically in requirements engineering, tradeoff analysis, risk management, configuration management, and verification and validation.
• Regulatory Familiarity:
  Experience working in a regulated environment, with familiarity with FDA, ISO, and other relevant regulatory standards for diagnostics products, especially regarding requirements, risk, and validation.
• Strategic Mindset:
  Demonstrated interest in innovative technologies and understanding of the competitive landscape in IVD, with an eye for potential risks, critical requirements, and robust validation approaches.
• Leadership and Communication:
  Proven ability to build authority and accountability within a team, with strong collaboration and communication skills, particularly in facilitating discussions around科学院​ requirements, risks, and validation plans.
• Haare Department: S pizz Competition large? We will ignore non relevant.

• Specialized
  
  Skills:
  
  Deep knowledge in requirements elicitation, risk analysis methodologies (e.g., FMEA), usability engineering, and V&V test strategy development.
• Technical Tools:
  Prior experience in RETINA (Requirements & Test Integration Application) and with Lucid Spark/Lucid Chart.
• Advanced Knowledge:
  Advanced understanding of software engineering, electronics, electro‑mechanical systems, information technology, and basic chemistry, to better define requirements, assess risks, and plan validation across system components.

26-00742

Mid‑Senior level

Contract

Information Technology

Staffing and Recruiting