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  3. Senior System Engineer

Senior System Engineer

Gentuity
Posted 3 months ago, valid for a month
Location

Sudbury, MA 01776, US

Salary

Competitive

Contract type

Full Time

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Sonic Summary

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  • This full-time role involves developing innovative medical imaging hardware and managing technical specifications throughout the design process.
  • The position requires a Bachelor's degree in electrical engineering or a related field, along with over 8 years of experience in the medical device industry.
  • Key responsibilities include driving compliance testing for electrical safety and EMC requirements, as well as supporting existing products with root cause analysis and redesign efforts.
  • Candidates should possess strong skills in system architecture, requirements management, and have familiarity with ISO standards and design control processes.
  • The role also involves coaching junior associates and collaborating with cross-functional teams, with a competitive salary offered commensurate with experience.

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 


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