Equipment Engineer
Core
Maintain, troubleshoot, optimize, and validate manufacturing equipment to ensure high uptime, product quality, and regulatory compliance in a medical device environment.
Role type
Equipment Engineer (Manufacturing)
Builds
Medical devices (sleep apnea, COPD equipment)
Domain
Medical device manufacturing / Regulated manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Equipment troubleshooting, maintenance, and optimization; Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ); Root Cause Analysis (RCA) and Corrective and Preventive Actions (CAPA); Lean Manufacturing and Six Sigma methodologies; Development of Work Instructions (WI) and Standard Operating Procedures (SOPs); Knowledge of GMP and ISO 13485 standards
Preferred skills
Six Sigma certification; Experience in medical device manufacturing; Exposure to automation, precision equipment, or cleanroom environments
Technologies
Lean Manufacturing tools; Six Sigma tools; Validation software
Responsibilities
Maintain, troubleshoot, and optimize manufacturing equipment; Lead equipment setup, installation, qualification, and commissioning; Execute IQ/OQ/PQ validation activities; Perform root cause analysis on equipment failures; Drive continuous improvement initiatives for cost reduction and yield improvement; Develop and maintain WI and SOP documentation
Seniority
Mid-level, hands-on IC
