Senior System Engineer

Tailored Management

Tucson (AZ)

On-site

USD 69,000 - 83,000

Full time

17 hours ago
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Benefits offered by this job

Weekly pay
Medical insurance
Dental insurance
Vision insurance

Job summary

Tailored Management is seeking a V-Model systems engineer to drive requirement translation and verification for medical-device focused programs. The role involves developing test methods, performing DoE, and analyzing sensor data on-site in Tucson.

Ideal candidates have 8+ years in regulated environments (FDA/FAA), strong skills in translating regulations into testable requirements, and experience with traceability matrices using RETINA/DOORS/Jira.

Qualifications

  • Bachelor's degree in engineering in Electrical, Chemical, Biomedical, or Software fields.
  • 8+ years of experience in a regulated environment (FDA/FAA) is a strong plus.
  • Experience translating regulatory standards into testable requirements.

Responsibilities

  • Test Method Development, DoE, data analysis (Python coding capability)
  • Digital outputs of a sensor and analyze the data
  • Executing hands-on testing protocols
  • Authoring detailed technical reports.
  • Managing the defect lifecycle (collection, documentation, and summarization for our development partner).

Skills

Python coding
Test planning
Regulatory translation
Traceability

Education

Bachelor's degree in engineering (Electrical, Chemical, Biomedical, or Software)

Tools

RETINA
DOORS
Jira

Job description

Location: 1910 East Innovation Park Drive Tucson AZ USA 85755

Contract Duration: 12+ Months (Potential for Extension or Full-Time Conversion)

Pay Rate: $50 –$60/hour (W2)

Benefits: Weekly Pay, Medical, Dental, and Vision Insurance

Work Model: Onsite

JOB DESCRIPTION
  • Deliver V-Model systems engineering outputs and participate in design reviews.
  • Conduct development and testing to evaluate performance against design specifications and system interactions.
  • Ensure assays operate efficiently and effectively using the latest technologies and systems.
  • Execute project deliverables—including requirements, risk, configuration management, defect management, and verification and validation—within the company-specific tool.
KEY RESPONSIBILITIES:
  • Test Method Development, DoE, data analysis (python coding capability)
  • Digital outputs of a sensor and analyze the data
  • Executing hands-on testing protocols
  • Authoring detailed technical reports.
  • Managing the defect lifecycle (collection, documentation, and summarization for our development partner).
PREFERRED QUALIFICATIONS:
  • Has expertise in translating industry standards, government regulations, and high-level stakeholder mandates into clear, testable engineering requirements.
  • Has experience and ability to read, interpret, and trace legal, safety, and industry regulations (e.g., ISO, IEC, FDA, EU standards) without losing intent.
  • Has experience in extracting functional, performance, interface, and constraint requirements from dense regulatory text and ambiguous stakeholder inputs.
  • Has experience breaking down high-level "shall" statements or compliance mandates into lower-level requirements for hardware, software, and system.
  • Has experience establishing bi-directional traceability (e.g., using tools like RETINA, DOORS, or Jira) linking source regulations → system requirements → design specifications → verification tests
EDUCATION & EXPERIENCE:
  • Degree: Bachelor's degree in engineering (Electrical, Chemical, Biomedical, or Software preferred)
  • Years of Experience: 8 yrs
  • Experience in a FDA or FAA regulated environment is a strong plus; Medical device industry is ideal
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