Senior Systems Engineer

• 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 defect lifecycles 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.

Seeking a hands-on Senior Systems Engineer with experience in electromechanical systems, system testing, and verification/validation, preferably within the medical device industry or an FDA/FAA-regulated environment., * Bachelor’s degree in Electrical, Chemical, Biomedical, Software Engineering, or a related engineering field.

• Hands-on experience with electromechanical systems, test method development, troubleshooting, and system verification/validation.

• Python coding skills for data analysis.

• Experience with requirements management and traceability tools such as DOORS, Jira, or RETINA.

Preferred Qualifications

• 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.