Lead Manufacturing Process Engineer
Core
Lead manufacturing process design, validation, and change management for medical technology products, ensuring quality, cost efficiency, and safety.
Role type
Senior IC manufacturing process engineer (medical devices)
Builds
Robust manufacturing processes, validated equipment, and cost-effective production lines for diagnostic imaging and electronics products
Domain
Medical technology / Healthcare manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process design and validation, Change management, PFMEA and quality planning, BOM and costing management, Corrective and preventive action (CAPA), Equipment verification and validation, Lean manufacturing and Kaizen, Plant layout optimization, NPI leadership, Safety matrix management
Preferred skills
Program management, Team leadership, Stakeholder management, ISO 13485 certification experience, Healthcare industry experience
Technologies
Oracle (BOM, Routing, Costing), PFMEA tools, DMR systems
Responsibilities
Lead process design, validation, and change management; Drive cost reduction and cycle time improvement; Manage equipment calibration and verification; Lead NPI programs and Kaizen initiatives; Ensure product quality trends and implement corrective actions; Maintain BOMs and cost targets with Finance; Optimize plant layout and safety processes
Seniority
Senior, hands-on IC with team management