Biomedical Systems Engineer/Senior Systems Engineer

ASK Consulting; Tucson (AZ); On-site; USD 62,000 - 83,000; Full time

Job summary

ASK Consulting seeks a Biomedical Systems Engineer/Senior Systems Engineer for an onsite Tucson, AZ role. This 12-month position requires hands-on experience with electro-mechanical devices and V-Model systems engineering.

Responsibilities include developing test methods, DoE and data analysis, performing testing, authoring technical reports, and managing defect lifecycles. FDA/FAA regulated environment experience is a strong plus; W2 payroll with full onsite support.

Qualifications

• Bachelor’s degree in Engineering or equivalent.
• 4+ years for Systems Engineer, 8+ years for Senior Systems Engineer.
• Experience in FDA or FAA regulated environments is a strong plus; Medical device industry is ideal.

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).

Skills

V-Model systems engineering

Requirements tracing

Regulatory compliance

DoE

Python data analysis

Education

Bachelor's degree in Engineering

Tools

RETINA

DOORS

Jira

Job description

\"All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment\".

Job Title: Biomedical Systems Engineer/Senior Systems Engineer

Location: Tucson, AZ (Onsite)

Duration: 12 Months

Pay rate: $45-60/hr On W2

Job Description :

This is an onsite position for a motivated, hands-on Systems Engineer or 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.

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.

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).

EDUCATION & EXPERIENCE:

• Degree: Bachelor's degree in Engineering (Electrical, Chemical, Biomedical, or Software preferred).
• Years of Experience: 4+ years for Systems Engineer level; 8+ years for Senior Systems Engineer level.
• Experience in an FDA or FAA regulated environment is a strong plus; Medical device industry is ideal.

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.