Sr. Manufacturing Engineer
Core
Lead manufacturing engineering activities to transfer Instruments & Accessories production lines from global plants to Penang, Malaysia site, ensuring compliance with medical device standards.
Role type
Senior Manufacturing Engineer (Medical Devices)
Builds
Production lines for surgical instruments and accessories
Domain
Medical device manufacturing
Required skills
Mechanical engineering, Manufacturing engineering, Validation and qualification (DQ/IQ/OQ/PQ/PPQ), Root cause analysis, Continuous improvement (First pass yield, cycle time), Design for Assembly/Manufacturability (DFA/DFM), Process documentation, Key Process Indicators (KPIs) definition, Supplier quality management, ISO 13485 compliance
Preferred skills
MS in Engineering, ISO 9001 experience, Solid modeling, Prototyping, Bilingual English
Technologies
Microsoft Office, Data analytics tools, Dashboards
Responsibilities
Lead production line transfers and equipment duplication, Oversee equipment validation and qualification, Provide day-to-day line support in Penang, Malaysia, Review and resolve quality notifications and implement corrective actions, Identify and implement continuous improvement projects, Provide Design Engineering input for DFA/DFM, Create and approve manufacturing documentation, Resolve supplier quality issues, Define and maintain KPIs using data analytics, Maintain compliance with medical device quality systems, Partner with plant leadership across functions, Travel to global Intuitive plants
Seniority
Senior, hands-on IC with team leadership