Tailored Management · 23 hours ago
Systems Engineer - Integration
Tucson, AZ
Contract
Hybrid
Mid Level
$42/hr - $45/hr
4+ years expTailored Management is seeking a Systems Engineer – Integration to join their R&D organization. This role involves driving requirements definition, risk management, and verification & validation activities across system-level projects to ensure compliance with IVD regulatory standards.
ConsultingHuman ResourcesInformation Technology
Responsibilities
Apply systems engineering best practices across requirements engineering, risk management, and verification & validation phases of the system lifecycle
Develop, analyze, and maintain system requirements, risk assessments, and traceability artifacts to ensure regulatory and business alignment
Plan and execute V&V activities, ensuring robust test strategies and compliance with applicable standards
Partner with R&D, Quality, Regulatory, Marketing, and Operations teams to ensure alignment on requirements, risks, and validation expectations
Engage with Voice of Customer (VoC) stakeholders and business leaders to translate customer needs into clear, testable system requirements
Analyze complex technical challenges, propose multiple solution paths, and support data-driven decision-making
Execute project deliverables related to requirements engineering, configuration management, defect tracking, risk analysis, and V&V using company-specific tools
Qualification
Required
Bachelor's degree in engineering, Biomedical Sciences, or related technical field with 4+ years of experience or Master's degree with 2+ years, or PhD
Strong understanding of systems engineering principles, including: Requirements engineering, Trade-off analysis, Risk management, Configuration management, Verification & validation
Experience working in a regulated environment with familiarity in FDA, ISO, or similar regulatory standards for diagnostic or medical device products
Preferred
Hands-on experience with risk analysis methodologies (e.g., FMEA)
Exposure to usability engineering and V&V test strategy development
Strong communication and facilitation skills, with the ability to lead discussions around requirements, risks, and validation plans
Excellent organizational skills with the ability to manage multiple priorities and complex documentation sets
Familiarity with assay development processes
Experience using RETINA (Requirements & Test Integration Application) and LucidSpark/LucidChart
Broad technical understanding across software, electronics, electro-mechanical systems, IT, and basic chemistry
Benefits
Weekly pay
Medical
Dental
Vision
Company
Tailored Management
Tailored Management is a staffing and recruiting company that offers information technology staffing and recruitment services.
501-1000 employees
H1B Sponsorship
Tailored Management 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
2024 (1)
2020 (2)
Funding
Current Stage
Late StageLeadership Team
Jeff Anderson
Managing Partner & Client Relations Executive
Savannah Deskins
Manager, Administration & Office of the CEO
Company data provided by crunchbase