Tailored Management · 5 hours ago
Systems Engineer - Assay Development
Tucson, AZ
Full-time
Hybrid
Mid Level
$42/hr - $45/hr
3+ years expConfidential company is seeking a Systems Engineer to support assay development projects as part of the R&D team. The role involves leading requirements definition, risk management, and verification and validation activities to ensure solutions meet applicable IVD and medical device standards.
ConsultingHuman ResourcesInformation Technology
Responsibilities
Define, document, and manage system and subsystem requirements in a regulated environment
Perform and support risk analysis activities, including FMEA
Apply systems engineering principles across requirements engineering, risk management, configuration management, and verification & validation
Partner cross-functionally with R&D, Quality, Regulatory, and other stakeholders to align requirements and project priorities
Support project execution by balancing technical, regulatory, and business tradeoffs
Qualification
Required
3–5 years of systems engineering experience in a regulated industry
Hands-on experience writing requirements (medical device industry strongly preferred)
Experience conducting risk analysis (FMEA) within an engineering discipline
Strong understanding of systems engineering fundamentals, including requirements engineering, risk management, tradeoff analysis, and V&V
Proven ability to collaborate cross-functionally and align diverse stakeholder needs
Bachelor's degree in engineering (required)
Preferred
Assay development experience, particularly with cytology specimens
Experience using RETINA (Requirements & Test Integration Application)
Familiarity with LucidSpark and/or LucidChart
Strong organizational skills with the ability to manage multiple priorities effectively
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