System Engineer
Core
SME validation and technical/process operations supporting product changes and manufacturing engineering in medical device production.
Role type
Manufacturing Engineering System Engineer
Builds
Engineered components and sub-systems for mission-critical applications (minimally invasive surgery, robotics, 3D metal printing)
Domain
Medical device manufacturing / Advanced manufacturing
Required skills
Risk management, test planning, technical documentation, statistical analysis, problem-solving tools (FMEA, 8D, Six Sigma), regulatory standards knowledge (ISO 13485, ISO 14791), SAP/ERP systems
Preferred skills
Mechanical or Manufacturing engineering background, medical materials knowledge, NGS (Novanta Growth System) principles
Technologies
SAP, MS Office (Excel, Word, PowerPoint), statistical tools
Responsibilities
Evaluate and document product changes based on system architecture and specifications, develop test and verification plans, monitor technical progress of product change projects, plan and execute product tests, create and maintain technical documentation and SOPs, collaborate with quality department for regulatory compliance, conduct validations, tests and data analysis, prepare verification/validation reports, organize test rooms and laboratories
Seniority
Mid-level, hands-on IC