System Engineer
Core
System Engineer responsible for SME validation, technical/process operations, and supporting Project Managers in strategic and operative tasks for medical device and advanced manufacturing products.
Role type
System Engineer (Validation & Technical Operations)
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
Validation planning, risk management, test method development, technical documentation, statistical analysis, problem-solving (FMEA, 8D, Six Sigma), regulatory standards knowledge (ISO 13485, ISO 14791), ERP systems (SAP)
Preferred skills
Mechanical or Manufacturing engineering background, knowledge of medical materials usage
Technologies
SAP, MS Office (Excel, Word, PowerPoint), FMEA, 8D, Six Sigma (via careerplan.io/jobs/R009756-system-engineer-at-novanta)
Responsibilities
Evaluate and document product changes based on system architecture and specifications; Develop test and verification plans for product changes; Monitor technical progress of product change projects; Plan and execute product tests; Create and maintain technical documentation and standard operating procedures; Collaborate with quality department for regulatory compliance; Lead adoption of NGS (Novanta Growth System) principles.
Seniority
Mid-level, hands-on IC
