Senior Systems Engineer, Biotech Onsite & Regulated

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

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.