Sr. System Engineer

Planet Pharma
Burlington, MA, United States
5 days ago

Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Experience level
Expert
Experience required
5 years minimum
Working hours
Regular working hours

Tech stack

Data Analysis Systems Engineering Software Documentation Software Debugging Firmware Failure Mode Effects Analysis Oracle (Applications) Systems Development Life Cycle Requirements Management Systems Architecture System Testing Systems Integration
+2 more
Jama (Software) Veeva

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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