Senior Systems Engineer

SPECTRAFORCE; Tucson (AZ); Presencial; USD 100.000 - 140.000; Jornada completa

Descripción de la vacante

Spectraforce is seeking a Senior Systems Engineer for an onsite role in Tucson, AZ. You will deliver V-Model systems engineering artifacts, participate in design reviews, and drive development and testing to verify performance against design specs for electro-mechanical devices.

You will translate regulatory requirements into testable system requirements, establish bi-directional traceability, and author technical reports while supporting Python-based data analysis and DoE activities with our

Formación

• Bachelor's degree in Engineering (Electrical, Chemical, Biomedical, or Software preferred).
• 8 years of experience in a regulated environment (FDA/FAA/Medical device ideal).
• Experience translating regulations into testable hardware/software requirements.

Responsabilidades

• Deliver V-Model system engineering artifacts and participate in design reviews.
• Conduct development and testing to verify performance against design specs.
• Translate regulatory requirements into testable system requirements and establish traceability across documents.
• Author detailed technical reports and manage defect lifecycle with development partner.

Conocimientos

Python data analysis

Regulatory compliance

Traceability

Design reviews

Educación

Bachelor's degree in Engineering

Herramientas

RETINA

DOORS

Jira

Descripción del empleo

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.