Solü Technology Partners · 12 hours ago
Systems Engineer - Software
Tucson, AZ
Full-time
Hybrid
Mid Level
$70K/yr - $90K/yr
4+ years expSolü Technology Partners is seeking a Systems Engineer – Software to support their client’s Product Definition team for an on-market product. This role focuses on software requirements, product risk management, and cross-functional collaboration to ensure product quality, safety, and performance in a regulated environment.
Information TechnologySoftwareStaffing Agency
Responsibilities
Writing software requirements to assess and mitigate product risk
Performing product risk management activities, including risk analysis, documentation, and mitigation related to product productivity and performance
Working with cross-functional teams to gather requirements, evaluate tradeoffs, and align technical solutions with business and customer needs
Applying systems engineering principles across the software lifecycle, including requirements engineering, software integration and testing, tradeoff analysis, configuration management, and verification/validation
Supporting quality and design documentation in compliance with FDA, ISO, and other applicable regulatory standards
Managing requirements, defects, and traceability in an Agile environment using Azure DevOps, Jira, Codebeamer, and Retina
Analyzing complex technical issues and presenting clear recommendations to stakeholders
Staying informed on emerging technologies and the IVD competitive landscape to support product differentiation and innovation
Qualification
Required
Bachelor's degree in Engineering, Biomedical Sciences, or a related technical field with 4+ years of experience, or Master's degree with 2+ years, or PhD with 0 years
Demonstrated systems engineering expertise in software integration and testing, requirements engineering, tradeoff analysis, configuration management, and verification/validation
Experience writing software requirements to assess product risk
Experience in product risk management
Experience working with cross-functional teams to gather needs, evaluate tradeoffs, and implement solutions
Ability to work independently and collaboratively to solicit needs and perform tradeoff analyses
Experience working in a regulated environment (medical devices preferred; aerospace or other regulated manufacturing environments acceptable)
Familiarity with FDA, ISO, and other relevant regulatory standards for diagnostic or medical device products
Interest in innovative technologies and understanding of the IVD competitive landscape
Experience producing and maintaining quality documentation
Preferred
Experience in the regulated medical device or IVD industry
Knowledge of software reliability, usability, and manufacturability
Strong organizational and communication skills
Company
Solü Technology Partners
This is Solü (sō-lu).
201-500 employees
H1B Sponsorship
Solü Technology Partners 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 (4)
2024 (1)
2023 (2)
2022 (1)
2021 (3)
Funding
Current Stage
Growth StageLeadership Team
Matt Cox
DevOps Lead/Amazon Web Services Engineer at Solu Technology Partners
Recent News
Rochester Business Journal
2024-03-08
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