System Engineer
Core
Validating product changes, managing technical documentation, and executing tests for medical device components and sub-systems.
Role type
System Engineer (Manufacturing/Validation)
Builds
Engineered components and sub-systems for minimally invasive surgery, robotics, and 3D metal printing.
Domain
Medical device manufacturing and advanced manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation planning, risk management (FMEA, 8D, Six Sigma), statistical analysis, technical documentation, regulatory standards knowledge (ISO 13485, ISO 14791), test execution, ERP systems (SAP)
Preferred skills
Mechanical or Manufacturing engineering background, knowledge of medical materials usage
Technologies
SAP, MS Office (Excel, Word, Powerpoint)
Responsibilities
Evaluate and document product changes based on system architecture, develop test and verification plans, monitor technical progress of product change projects, plan and execute product tests, create and maintain technical documentation, collaborate with quality department for regulatory compliance, conduct validations, tests and data analysis, prepare and review verification/validation plans/reports, develop test methods, organize test rooms and laboratories
Seniority
Entry-level to Mid-level, hands-on IC
