NPI Engineer - R&D
Core
Lead design transfer activities and deliver projects supporting the Infusion Care product range, transitioning designs from Science & Innovation to manufacturing.
Role type
Senior IC NPI Engineer (Medical Devices)
Builds
Medical device products and manufacturing processes for Infusion Care
Domain
Medical Devices / Infusion Care / Manufacturing Engineering
Required skills
Design transfer, process validation, risk management, project management, CAD/CAM (SolidWorks, AutoCAD), regulatory compliance (ISO 13485, 21 CFR 820), material specification, prototyping, change control management
Preferred skills
PMP certification, Green Belt certification, IDEAL stage gate process knowledge, product/process validation experience
Technologies
SolidWorks, AutoCAD, QMS-SAP, CAD/CAM software
Responsibilities
Develop processes and specifications for new product development; lead team assignments and project execution; evaluate project requirements and estimate time to completion; prioritize resource deployment; ensure feasibility work, analysis, validation, and testing meet Quality and Regulatory standards; maintain technical knowledge of manufacturing processes; lead design and development of medical devices from concept to launch; create 3D models and assemblies; resolve concepts via prototyping; participate in design for manufacturing and assembly discussions; support process validations (OQ, PQ); plan and execute special test runs; lead introduction of manufacturing equipment; integrate EHS and Energy requirements into new product introductions
Seniority
Senior, hands-on IC