Senior Systems Test Engineer – Medical Devices

Spectraforce; Tucson (AZ); On-site; USD 110,000 - 150,000; Full time

Job summary

Spectraforce is seeking a hands-on Senior Systems Engineer for an onsite 12-month assignment to develop and verify electro-mechanical devices in a regulated environment.

The role focuses on delivering V-Model system engineering outputs, performing development and testing to meet design specifications, and authoring detailed technical reports while maintaining traceability across requirements, designs, and verification activities.

Qualifications

• 8 years of engineering experience in FDA/FAA regulated environments.
• Experience translating regulations into testable requirements.
• Ability to read and trace ISO, IEC, FDA, EU standards.
• Experience deriving lower-level requirements from high-level mandates.
• Bi-directional traceability using RETINA, DOORS, or Jira.

Responsibilities

• Deliver V-Model systems engineering outputs and participate in design reviews.
• Conduct development and testing to evaluate performance against design specifications.
• Ensure assays operate efficiently using the latest technologies and systems.
• Execute project deliverables including requirements, risk, configuration management, defect management, and verification and validation.

Skills

Python

Data analysis

Requirements tracing

Hands-on testing

Systems engineering

Education

Bachelor's degree in Engineering

Tools

RETINA

DOORS

Jira

Job description

Assignment Duration: 12 months

Work Arrangement:Onsite

Position Summary: This is an onsite position for a motivated, hands‑on Senior Systems Engineer who has experience with electro-mechanical devices.

SUMMARY:

• 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:

• TMV, 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).

Qualification & Experience:

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

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.