Systems Engineer

Job Description

Our client, a world leader in diagnostics and life sciences, is looking for a “Systems Engineer” based out of Tucson, AZ. Job Duration:
Long term Contract (Possibility Of Further Extension) Pay Rate: $39/hr on W2 Company Benefits:
Medical, Dental, Vision, Paid Sick leave, 401K

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 tradeoffs.

• 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 software differentiation and creative solutions.
• Execute project deliverables specific to software requirements, risk analysis, configuration management, defect management, and verification & validation in the company-specific tool.

• 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).
• Demonstrated knowledge of systems engineering principles, specifically in requirements engineering, tradeoff analysis, risk management, configuration management, and verification & validation.
• 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. 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.

• Deep knowledge in requirements elicitation, risk analysis methodologies (e.g., FMEA), usability engineering, and V&V test strategy development.
• Assay Development:
  Familiarity with the assay development process and its associated requirements, risks, and validation needs.
• 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.

If interested, please send us your updated resume at/

Dawar Consulting