Sharp Decisions · 1 day ago
Systems Engineer – Software & Risk
Tucson, AZ
Contract
Onsite
Mid Level
$42/hr - $45/hr
4+ years expSharp Decisions is seeking a Systems Engineer to drive software product definition, including requirements, system architecture design, risk analysis, and solution implementation to meet IVD standards. This role focuses on advancing cancer diagnostics through state-of-the-art testing automation, providing over 250 cancer tests and associated instruments globally.
B2BHuman ResourcesInformation TechnologyStaffing Agency
Hiring Manager
Jetendra Singh
Responsibilities
System Lifecycle Management: Apply Systems Engineering to SW product definition, requirements, risk analysis, and testing
Project Execution: Manage software requirements, risk analysis, configuration, defect management, and verification/validation
Industry and Technology Analysis: Research trends, emerging technologies, and competitive products for software differentiation
Cross-functional Collaboration: Work with R&D, Marketing, Operations, Quality, and Regulatory teams to ensure alignment
Customer-Focused Innovation: Engage with business leaders and VoC representatives to align technical solutions with customer needs
Technical Problem Solving: Analyze complex technical challenges, present solutions, and facilitate informed decision-making
Qualification
Required
Experience writing SW requirements and completing risk analysis
Ability to work independently and cross-functionally with many different groups to solicit needs and complete trade off analyses
Experience in a regulated medical device industry
Bachelor's degree in Engineering, Biomedical Sciences, or related technical field with 4 years of experience (or Masters with 2 years, or PhD)
Demonstrated knowledge in software integration and testing, including requirements engineering, tradeoff analysis, risk management, configuration management, and verification/validation
Experience in a regulated environment, familiar with FDA, ISO, and other relevant diagnostic product standards
Interest in innovative technologies and understanding of the IVD competitive landscape
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, capable of evaluating, prioritizing, and managing multiple projects efficiently
Company
Sharp Decisions
Sharp Decisions is a staffing and recruiting company that offers technology and business staffing solutions.
201-500 employees
H1B Sponsorship
Sharp Decisions 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 (6)
2024 (13)
2023 (2)
2022 (10)
2021 (7)
2020 (10)
Funding
Current Stage
Growth StageLeadership Team
Karen Ross
Founder, President and CEO
Stuart Gottlieb
CFO/COO and Principal
Company data provided by crunchbase