Sr. System Engineer
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Job description
Experteer Overview In this role you will drive end-to-end system development, integration, and verification for a complex electromechanical medical device. You will work closely with hardware, software, firmware, mechanical, quality, and regulatory teams to ensure requirements are implemented and validated. The position is hands-on and execution-focused, emphasizing cross-functional collaboration to resolve system-level issues. You will shape system performance and ensure compliance while supporting V&V activities and change management as projects evolve. Compensation / Benefits * Support system-level requirements management and traceability (Helix or Jama) * Define architecture and interfaces across hardware, software, firmware, and mechanical domains * Maintain system documentation and design artifacts * Create and maintain test fixtures and documentation for test results * Lead system integration activities and support V&V, testing, and data analysis * Participate in system bring-up, debugging, and performance analysis * Collaborate with SMEs to investigate and resolve system-level issues * Develop system test plans, protocols, and procedures * Conduct system/subsystem testing including bench tests, simulations, and evaluations * Manage ECOs and lifecycle updates via Oracle and Veeva * Support risk management activities (hazard analysis, FMEA) and compliance documentation * Assist with design control and regulatory audits * Ensure documentation reflects released changes and supports cross-functional impact assessments Tasks * Bachelor’s degree in electrical engineering or related field; advanced degree preferred * 5+ years in system engineering within the medical device industry * Proven experience in architecture, system-level design, integration and verification of complex electro-mechanical devices * Hands-on system integration, testing, and troubleshooting * Experience with requirements management tools (e.g., Helix, Jama) * Development experience in software, mechanical, electrical, optics disciplines * Understanding of regulatory standards (60601-1, 60601-2, 60601-1-6) and safety compliance * Strong collaboration and communication across functions and external partners * Detail-oriented with analytical and problem-solving abilities Key requirements *
Requirements
and debugging, and performance analysis * Collaborate with SMEs to investigate and resolve system-level issues * Develop system test plans, protocols, and procedures * Conduct system/subsystem testing including bench tests, simulations, and evaluations * Manage ECOs and lifecycle updates via Oracle and Veeva * Support risk management activities (hazard analysis, FMEA) and compliance documentation * Assist with design control and regulatory audits * Ensure documentation reflects released changes and supports cross-functional impact assessments Tasks * Bachelor’s degree in electrical engineering or related field; advanced degree preferred * 5+ years in system engineering within the medical device industry * Proven experience in architecture, system-level design, integration and verification of complex electro-mechanical devices * Hands-on system integration, testing, and troubleshooting * Experience with requirements management tools (e.g., Helix, Jama) * Development experience in aaaaaaa in mechanical, electrical, optics disciplines * Understanding of regulatory standards (60601-1, 60601-2, 60601-1-6) and safety compliance * Strong collaboration and communication across functions and external partners * Detail-oriented with analytical and problem-solving abilities Key requirements *
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