System Integration Engineer - Medical Device Systems

DHANU GLOBAL ENTERPRISES, INC.
Palo Alto, CA, United States
6 days ago
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Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Experience level
Expert
Experience required
10 years minimum
Compensation
$540.0 - $660.0
Working hours
Regular working hours
Job source

Tech stack

Adobe InDesign Systems Engineering Automation of Tests Software Debugging Firmware Failure Mode Effects Analysis Imaging Technology Verification and Validation (Software) Systems Integration Diagnostic Tools System-level Testing Integration Tests
+1 more
Hardware Debugging

Job description

  • Define system level interface specifications & drive system integration plan.

  • Integrate hardware, software, firmware, controls, imaging and electromechanical subsystems into complete medical-device systems during development phase.

  • Plan and execute system integration, verification and validation activities to ensure product performance, reliability and safety.

  • Perform hands-on integration, prototype bring-up, debugging and troubleshooting of complex electromechanical systems.

  • Investigate system-level issues and perform root-cause analysis using logs, diagnostic tools and engineering data.

  • Troubleshoot interoperability, timing, communication and interface-related defects across multiple subsystems.

  • Collaborate with Systems, Electrical, Software, Mechanical, Quality and Manufacturing Engineering teams to resolve technical challenges.

  • Collaborate with Verification & Validation team in developing and executing integration test plans, test procedures and verification protocols.

  • Independently drive defect investigation, resolution and corrective actions through cross-functional collaboration.

  • Participate in design reviews, integration readiness reviews, risk assessments and FMEA activities.

  • Document test results, issue investigations, verification evidence and engineering recommendations.

  • Support design-control documentation and system verification evidence in regulated medical-device environments.

  • Identify opportunities to improve integration processes, test automation and engineering efficiency.

Requirements

Education: Bachelor//’s or Master//’s degree in electrical engineering, Electronics Engineering, Systems Engineering, or a related discipline., * 10+ years of experience in system integration, verification, validation, product development or sustaining engineering.

  • Strong understanding of complex electromechanical systems, embedded systems and hardware-software interactions.

  • Hands-on experience debugging hardware, firmware, software, controls and communication interfaces.

  • Experience developing test plans and troubleshooting multidisciplinary engineering systems.

  • Working knowledge of system-level testing methodologies and defect management processes.

  • Strong analytical and problem-solving skills, with the ability to independently investigate and resolve complex technical issues.

  • Excellent technical documentation, communication and cross-functional collaboration skills.

Preferred Qualifications

  • Experience with medical-device product development, design controls and verification documentation.

  • Familiarity with ISO 13485, ISO 14971 and IEC 60601 or equivalent regulated product standards.

  • Experience with radiation therapy equipment, imaging systems, medical instrumentation or other complex safety-critical electromechanical products.

  • Experience with test automation, diagnostic tools and system integration laboratories.

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