Sr. Manufacturing Engineer
Core
Leads fabrication, installation, operation, maintenance, and repair of mechanical and electromechanical manufacturing systems for medical device product lines.
Role type
Senior Manufacturing Engineer (Medical Devices)
Builds
Medical device manufacturing processes and equipment
Domain
Medical device manufacturing / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process validation (IQ/OQ/PQ), Root cause analysis (RCA), CAPA investigations, Lean and Six Sigma methodologies, Design for manufacturability (DFM), Equipment specification and procurement, Preventive maintenance, Regulatory audit support, Statistical analysis (Cpk, Gage R&R)
Preferred skills
Six Sigma Green/Black Belt certification, Class II/III medical device experience, Risk management (ISO 14971), FMEA methodologies, CAD tools (SolidWorks), ERP/MES systems, Sterilization methods knowledge
Technologies
SolidWorks, ERP/MES systems
Responsibilities
Design and validate manufacturing processes; Lead root cause analysis and corrective actions; Apply Lean/Six Sigma to reduce defects and costs; Partner with R&D on design transfer; Define equipment specs and lead procurement; Maintain calibration and preventive maintenance programs; Support internal and regulatory audits
Seniority
Senior, hands-on IC