Job Title: Senior Systems Engineer
Duration: 12 months with Possible extension
Mode: 100% onsite, five days per week
Locations: Oro Valley Arizona 85755
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.
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
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).