Job Description
Job Description
Staff Engineer, System Engineering Lead (Natick, MA) – Lead cross-functional system development for complex medical devices, including requirements analysis, system architecture, verification & validation, and design transfer to manufacturing using Manufacturing Systems Engineering, DOE (Experimental Design), and Statistical Sampling Plan; Conduct risk management, including FMEA (Failure Mode Effect Analysis) and FTA (Fault Tree Analysis), to identify potential hazards and implement mitigation strategies; Drive Corrective and Preventive Actions (CAPA) by performing root cause analysis using engineering analysis methods, including Deformation and Fracture Analysis; Identify complaint trends and prioritize quality investigation using Data Analytics; Monitor and analyze critical-to-quality (CTQ) parameters in medical device production by implementing SQC (Statistical Quality Control), including control charts and process capability analysis, and Production Systems Analysis techniques to detect anomalies, predict process variability trends; Perform reliability analysis to critical medical device components using statistical lifetime modeling of time-to-failure data to optimize preventive maintenance strategies and meet reliability requirements.
Must have a Master’s Degree in Industrial & Systems Engineering, Mechanical Engineering, or Biomedical Engineering plus skills and knowledge in SQC, Production Systems Analysis, Manufacturing Systems Engineering, DOE, Data Analytics, Deformation and Fracture Analysis.
Job location: Natick, MA. Allow telecommuting. $119,398 to $125k/yr.
Submit résumé referencing job code JIL010 to HR, Intuvie, 177 Pine Street, Natick, MA 01760.