Responsibilities

Job Title:

Systems Engineer Specializing in Software Integration and Testing

Responsibilities include:

• System Lifecycle Management:
  Apply broad knowledge and skill-sets from Systems Engineering, focusing on the software integration and testing 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.
• Cross-functional Collaboration:
  
  Work closely with R&D, Marketing, Operations, Quality, and Regulatory teams to ensure alignment with organizational objectives and regulatory requirements.
• 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 software features and enhancements.
• Technical Problem Solving:
  Analyze complex technical challenges, present multiple solution paths, and help stakeholders make informed decisions; provide innovative and clear options to address software integration and testing challenges.
• Project Execution:
  Execute project deliverables specific to software requirements, risk analysis, configuration management, defect management, and verification and validation in the company-specific tool.

Who You Are

• 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 systems engineering principles, specifically in software integration and testing, including 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.
• Strategic Mindset:
  Demonstrated interest in innovative technologies and understanding of the competitive landscape in IVD.

Preferred

• Specialized
  
  Skills:
  
  Deep knowledge in software 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, with the ability to efficiently evaluate, prioritize, and handle multiple projects and priorities; capability to formulate and solve problems, and complete work in a timely, accurate, and thorough manner.
• Assay Development:
  Familiarity with the assay development process.
• 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.
• This tailored job description is focused on a Systems Engineer specializing in software integration and testing within the exciting and innovative field of cancer diagnostics.