Systems Engineer (Software Integration and Testing) jobs in United States
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Software Guidance & Assistance, Inc. (SGA, Inc.) ยท 3 hours ago

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 a premier Pharmaceutical Services client. The role involves driving assay and software integration and testing practices, defining requirements, and implementing solutions to meet IVD standards while collaborating closely with various teams to align technical solutions with customer needs.

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H1B Sponsor Likelynote

Responsibilities

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

Qualification

Systems engineering principlesSoftware integrationTestingRegulatory standards knowledgeRisk managementConfiguration managementVerificationValidationAssay developmentRETINALucidSpark/LucidChartIVD technologiesBasic chemistry knowledgeCollaboration skillsCommunication skillsOrganizational skillsProblem-solving skills

Required

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

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

Company

Software Guidance & Assistance, Inc. (SGA, Inc.)

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SGA is the technology and resource solutions provider driven to stand out. We are a certified women-owned business.

H1B Sponsorship

Software Guidance & Assistance, Inc. (SGA, Inc.) has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (12)
2023 (19)
2022 (25)
2021 (41)
2020 (44)

Funding

Current Stage
Growth Stage

Leadership Team

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Peter Taylor
CEO
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Andrew Gallagher - CCWP
Senior Vice President - Strategic Partnerships
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Company data provided by crunchbase