Senior Systems Engineer

Solü Technology; Oro Valley (AZ); On-site; USD 110,000 - 150,000; Full time

Job summary

Solü Technology Partners seeks a Senior Systems Engineer for an onsite role focused on electro‑mechanical devices. You will translate regulations into clear requirements and establish traceability across hardware, software, and system components.

You will lead development and testing to verify performance against design specs, manage defect lifecycles, and document results in formal reports. Experience with FDA/IEC standards is highly valued.

Qualifications

• Translates industry standards, regulations, and stakeholder mandates into clear, testable requirements.
• Reads and traces regulatory texts (ISO, IEC, FDA, EU standards) without losing intent.
• Extracts functional, performance, interface, and constraint requirements from dense text.

Responsibilities

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

Skills

Regulatory requirements translation

Requirements extraction

Traceability planning

System engineering

Education

Bachelor’s degree in Engineering (Electrical, Chemical, Biomedical, or Software preferred)

Tools

RETINA

DOORS

Jira

Job description

Our partner ranks among the world’s prominent corporations in the biotechnology industry. Working on their team means you’ll impact the lives of millions of patients and be a part of a culture of innovation, curiosity, and diversity.

Employment Requirements

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

This opportunity is for local candidates only.

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
• Test bed development
• Troubleshooting skills
• Developing comprehensive testing plans.
• 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

*Solü Technology Partners provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, national origin, age, disability or genetics.