Senior Systems Engineer

Benefits: Medical, Paid Sick leave, 401K 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.

Key

Responsibilities: 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. Required

Qualifications: 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. If interested, please send us your updated resume at [email protected]/[email protected]