Senior System Engineer

Solü Technology Partners; Oro Valley (AZ); On-site; USD 110,000 - 160,000; Full time

Job summary

Solü Technology Partners in Tucson, AZ is seeking a hands-on Senior Systems Engineer with electro-mechanical device experience for an onsite role. The candidate will translate regulatory requirements into testable specs and deliver robust system engineering outputs throughout the project lifecycle.

Key tasks include DoE/data analysis (Python), managing defect lifecycles, and authoring detailed technical reports while ensuring compliance with ISO/IEC/FDA standards and traceability across

Qualifications

• Translates industry standards, gov regulations, and stakeholder mandates into clear, testable requirements.
• Reads and traces regulations (ISO, IEC, FDA, EU) to maintain compliance.
• Extracts functional, performance, interface, and constraint requirements from dense regulatory text.

Responsibilities

• 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.

Skills

System engineering

Regulatory translation

Requirements tracing

Education

Bachelor's degree in Engineering

Tools

RETINA

DOORS

Jira

Job description

This opportunity is not open to C2C relationships or visa sponsorship.

This opportunity is for local candidates only. Out of state candidates may apply but must be willing to relocate themselves to the Tucson, AZ area within 2 weeks after an offer.

Job Description

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

• 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).

Responsibilities

• 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.

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

Additional Qualifications

• 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