Senior System Engineer

Company : Gentuity, LLC

Job Type : Full Time

Sudbury, United States

Job Description - Senior System Engineer

Full-time

Description

Full-time, hands-on role inventing practical solutions to develop top-tier medical imaging hardware
Write and manage technical specifications (system, subsystem, and interface specs) and trace requirements through design, verification, and validation.
Drive compliance testing strategy and execution for IEC 60601-1 electrical safety and IEC 60601-1-2 EMC requirements; coordinate lab testing, pre-compliance, and corrective actions. Plan and execute subsystem tests, systems integration and testing, and formal verification tests for medical devices
Support existing released products with root cause failure analysis, redesign for cost reduction, and iterations based on market feedback
Support manufacturing troubleshooting and complaints investigations as required
Lead communication with remote teams as Systems Engineering lead
Work effectively in cross-functional teams consisting of Research, Engineering, QA/RA, Marketing, Operations, Finance and other functions as a team player
Contribute to intellectual property creation and documentation
Coach and delegate tasks to junior associates

Requirements

Bachelor's degree in electrical engineering (BSEE) or related field required, with 8+years of work experience in medical device industry
Strong understanding of ISO 13485, IEC 60601-1, 3.1 edition Safety and Essential performance and IEC60601-1-2 4th edition Electromagnetic disturbances
Strong skills in system architecture, requirements management, and specification writing.
Experience with photonic/optical system design and development is a plus
Familiarity with risk management (ISO 14971) and design control processes (21 CFR 820 / MDR equivalents).
Must have experience integrating, testing, and verifying complex medical systems
Experience with schematic capture, PCBA design and testing, motion control system is a plus
Extensive experience working with consultants, outside partners, contract manufacturers and suppliers
Ability to independently organize/align project tasks with department/corporate priorities

Salary Description

$120,000 - $160,000

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Senior System Engineer

Job Description - Senior System Engineer

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