Senior Systems Engineer

Seeking a hands-on Senior Systems Engineer with electro-mechanical device experience to execute systems engineering activities, testing, and verification and validation. The role involves V-Model systems engineering, sensor data analysis, test bed development, and defect lifecycle management in a regulated engineering environment.

Systems Engineering, Systems Engineering, Testing, Data Analysis, Test Plan/Schedule, Bug Tracking/Defect Management, Electromechanical Systems, Electromechanical Engineering, Validation Testing, Biomedical Software, * Bachelor’s degree in Engineering (Electrical, Chemical, Biomedical, or Software preferred)

• 8+ years of relevant engineering experience, * Systems engineering using the V-Model and participation in design reviews
• Electro-mechanical device development and testing
• Test Method Validation (TMV), test method development, and Design of Experiments (DoE)
• Python coding for data analysis and interpretation of digital sensor outputs
• Test bed development, hands-on testing protocols, and test plan development
• Requirements management, risk management, configuration management, and defect lifecycle management
• Verification and validation against design specifications and system interactions
• Technical report authoring and defect documentation

Preferred Skills

• Experience in FDA- or FAA-regulated environments, preferably medical devices
• Translating industry standards, government regulations, and stakeholder mandates into testable engineering requirements
• Interpreting ISO, IEC, FDA, and EU regulatory standards
• Decomposing high-level compliance requirements into hardware, software, and system-level requirements
• Establishing bidirectional requirements traceability from regulations through system requirements, design specifications, and verification tests
• Experience with requirements management tools such as RETINA, IBM DOORS, or Jira