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Job Requirements of Systems Engineer - Assay Development:
-
Employment Type:
Full-Time
-
Location:
Tucson, AZ (Onsite)
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Systems Engineer - Assay Development
Tailored Management Services Inc
Tucson, AZ (Onsite)
Full-Time
Job Title: Systems Engineer – Assay Development
Location: 1910 East Innovation Park Drive, Tucson, AZ 85755
Duration: 10-month contract (with potential extension or conversion)
Pay Rate: $42–$45/hour (W2)
Schedule: Monday–Friday, 8:00 AM–5:00 PM
Work Model: Hybrid (minimum 3 days onsite per week)
Benefits: Weekly pay, Medical, Dental, Vision
Position Overview
As part of the R&D team, the Systems Engineer will support assay development projects by leading requirements definition, risk management, and verification and validation activities. This role is responsible for translating user and regulatory needs into clear system requirements, contributing to system architecture design, and ensuring solutions meet applicable IVD and medical device standards.
The ideal candidate will take ownership of assigned deliverables, collaborate closely with cross-functional stakeholders, and support informed decision-making by evaluating tradeoffs and risks throughout the development lifecycle.
Key Responsibilities
Preferred Qualifications (Nice to Have)
Location: 1910 East Innovation Park Drive, Tucson, AZ 85755
Duration: 10-month contract (with potential extension or conversion)
Pay Rate: $42–$45/hour (W2)
Schedule: Monday–Friday, 8:00 AM–5:00 PM
Work Model: Hybrid (minimum 3 days onsite per week)
Benefits: Weekly pay, Medical, Dental, Vision
Position Overview
As part of the R&D team, the Systems Engineer will support assay development projects by leading requirements definition, risk management, and verification and validation activities. This role is responsible for translating user and regulatory needs into clear system requirements, contributing to system architecture design, and ensuring solutions meet applicable IVD and medical device standards.
The ideal candidate will take ownership of assigned deliverables, collaborate closely with cross-functional stakeholders, and support informed decision-making by evaluating tradeoffs and risks throughout the development lifecycle.
Key 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
- 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
Preferred Qualifications (Nice to Have)
- 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
- Bachelor's degree in engineering (required)
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