Senior Systems Engineer

Planet Pharma; Tucson (AZ); On-site; USD 69,000 - 83,000; Full time

Job summary

Planet Pharma in Tucson, AZ is seeking a motivated Systems Engineer or Senior Systems Engineer for an onsite role concentrating on electro-mechanical devices. You will deliver V-Model systems engineering outputs, conduct development and testing, and ensure assays operate efficiently using the latest technologies and systems.

The ideal candidate has experience translating regulations into clear engineering requirements, can interpret ISO/IEC FDA/EU standards, and will contribute to traceability

Qualifications

• Bachelor's degree in Engineering (Electrical, Chemical, Biomedical or Software preferred).
• 4+ years for Systems Engineer level; 8+ years for Senior Systems Engineer level.
• Experience in FDA or FAA regulated environments is a strong plus; Medical device industry is ideal.
• Ability to translate regulations into testable requirements and traceability.

Responsibilities

• TMV, Test Method Development, DoE, data analysis.
• Digital outputs of a sensor and analyze the data.
• Test bed development.
• Troubleshooting skills and hands-on testing protocols.
• Developing comprehensive testing plans.
• Executing hands-on testing protocols.
• Authoring detailed technical reports.
• Managing the defect lifecycle with development partner.

Skills

Test Method Development

Design of Experiments (DoE)

Python scripting

Sensor data analysis

Test bed development

Troubleshooting

Testing plans

Hands-on testing

Technical reporting

Defect lifecycle management

Education

Bachelor's degree in Engineering

Tools

RETINA

DOORS

Jira

Job description

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.
• 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).

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.

Pay Rate Range: $50-60/hr depending on experience