Senior Systems Engineer - Regulated Medical Devices

Tailored Management; Tucson (AZ); Presencial; USD 69 000 - 83 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Weekly pay

Medical insurance

Dental insurance

Vision insurance

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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).

Conhecimentos

Python coding

Test planning

Regulatory translation

Traceability

Formação académica

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

Ferramentas

RETINA

DOORS

Jira

Descrição da oferta de emprego

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.