Senior Systems Engineer

Tucson, United States

Our client, a world leader in biotechnology and life sciences, islooking for a“Senior Systems Engineer” based in Tucson, AZ.

• Medical, Paid Sick leave,401K

Seeking a hands-on Senior Systems Engineer with experience inelectromechanical systems, system testing, and verification/validation,preferably within the medical device industry or an FDA/FAA-regulated environment.

• Develop and execute system engineering deliverables following the V-Model and participate in design reviews.
• Develop test methods, test beds, and comprehensive testing plans; perform TMV,DOE, and hands-on system testing.
• Analyze sensor outputs and test data using Python and other data analysis techniques.
• Evaluate system performance against design specifications and troubleshoot system-level issues.
• Manage requirements, risk, configuration, verification/validation, and defectlifecycles using designated engineering tools.
• Author detailed technical reports and document test results, defects, and findings for development partners.
• Translate regulatory standards and stakeholder needs into clear, testable system,hardware, and software requirements.
• Maintain bidirectional traceability from regulations and requirements through design specifications and verification tests.

• Bachelor’sdegree in Electrical, Chemical, Biomedical, Software Engineering, or arelated engineering field.
• Hands-on experience with electromechanical systems, test method development,troubleshooting, and system verification/validation.
• Experience with requirements management and traceability tools such as DOORS, Jira,or RETINA.

• Experience in the medical device industry or an FDA/FAA-regulated environment.
• Knowledge of ISO, IEC, FDA, and EU regulatory standards.
• Experience interpreting regulations and translating compliance requirements into system-level and lower-level engineering requirements.