System Integration Engineer - Medical Device Systems
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Role details
Tech stack
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Job description
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Define system level interface specifications & drive system integration plan.
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Integrate hardware, software, firmware, controls, imaging and electromechanical subsystems into complete medical-device systems during development phase.
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Plan and execute system integration, verification and validation activities to ensure product performance, reliability and safety.
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Perform hands-on integration, prototype bring-up, debugging and troubleshooting of complex electromechanical systems.
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Investigate system-level issues and perform root-cause analysis using logs, diagnostic tools and engineering data.
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Troubleshoot interoperability, timing, communication and interface-related defects across multiple subsystems.
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Collaborate with Systems, Electrical, Software, Mechanical, Quality and Manufacturing Engineering teams to resolve technical challenges.
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Collaborate with Verification & Validation team in developing and executing integration test plans, test procedures and verification protocols.
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Independently drive defect investigation, resolution and corrective actions through cross-functional collaboration.
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Participate in design reviews, integration readiness reviews, risk assessments and FMEA activities.
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Document test results, issue investigations, verification evidence and engineering recommendations.
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Support design-control documentation and system verification evidence in regulated medical-device environments.
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Identify opportunities to improve integration processes, test automation and engineering efficiency.
Requirements
Education: Bachelor//βs or Master//βs 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.
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Strong understanding of complex electromechanical systems, embedded systems and hardware-software interactions.
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Hands-on experience debugging hardware, firmware, software, controls and communication interfaces.
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Experience developing test plans and troubleshooting multidisciplinary engineering systems.
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Working knowledge of system-level testing methodologies and defect management processes.
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Strong analytical and problem-solving skills, with the ability to independently investigate and resolve complex technical issues.
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Excellent technical documentation, communication and cross-functional collaboration skills.
Preferred Qualifications
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Experience with medical-device product development, design controls and verification documentation.
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Familiarity with ISO 13485, ISO 14971 and IEC 60601 or equivalent regulated product standards.
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Experience with radiation therapy equipment, imaging systems, medical instrumentation or other complex safety-critical electromechanical products.
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Experience with test automation, diagnostic tools and system integration laboratories.
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