Sr Process Engineer
Core
Serve as the Subject Matter Expert for manufacturing processes, leading continuous improvement, validation, and operational support for medical device production.
Role type
Senior Process Engineer (Medical Device Manufacturing)
Builds
Medical device manufacturing processes and equipment reliability
Domain
Medical Technology / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Lean Manufacturing, Six Sigma, Root Cause Analysis, Validation Protocols, OEE Analysis, Capital Project Management, Equipment Reliability, Regulatory Compliance (FDA), Process Documentation, Cross-functional Leadership
Preferred skills
Medical device manufacturing experience, DMAIC methodology, Statistical analysis
Technologies
FDA regulations, Quality System requirements, CB2 requests, EHS standards
Responsibilities
Lead validation activities (IQ/OQ/PQ/CSV) in compliance with FDA regulations; Drive Lean Manufacturing and continuous improvement initiatives to increase productivity and quality; Serve as technical lead for manufacturing floor problem-solving using structured methodologies; Manage equipment acquisition, installation, and preventive maintenance programs; Evaluate manufacturing capacity and prepare capital expenditure requests; Provide coaching and technical guidance to engineering technicians and operations personnel.
Seniority
Senior, hands-on IC
