Systems Engineer (Software Integration and Testing)

Software Guidance & Assistance, Inc., (SGA), is searching for a Systems Engineer (Software Integration and Testing) for a CONTRACT assignment with one of our premier Pharmaceutical Services clients in Tucson, AZ.

Responsibilities:

As a member of our R&D team, the Systems Engineer will drive assay and software integration and testing 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 software integration and testing stages of the system lifecycle.
• Research and analyze industry trends, emerging technologies, and competitive products to identify opportunities for software differentiation and creative solutions.
• Work closely with R&D, Marketing, Operations, Quality, and Regulatory teams to ensure alignment with organizational objectives and regulatory requirements.
• 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.
• 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.
• Execute project deliverables specific to software requirements, risk analysis, configuration management, defect management, and verification and validation in the company-specific tool.
  
  

Required Skills:

• 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 software integration and testing, including requirements engineering, tradeoff analysis, risk management, configuration management, and verification and validation.
• Experience working in a regulated environment, with familiarity with FDA, ISO, and other relevant regulatory standards for diagnostics products.
• Demonstrated interest in innovative technologies and understanding of the competitive landscape in IVD.
  
  

Preferred Skills:

• Deep knowledge in software reliability, manufacturability, and usability.
• Proven ability to build authority and accountability within a team, with strong collaboration and communication 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.
• Familiarity with the assay development process.
• Prior experience in RETINA (Requirements & Test Integration Application) and with LucidSpark/LucidChart.
• Advanced understanding of software engineering, electronics, electro-mechanical systems, information technology, and basic chemistry.
  
  

SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at https://sgainc.com/ .

SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company EEO page to request an accommodation or assistance regarding our policy.