Sr. Mechanical Engineer, Equipment
Core
Design, duplicate, construct, and validate manufacturing equipment for minimally invasive medical devices, transferring production lines from global sites to Penang, Malaysia.
Role type
Senior Mechanical Engineer (Equipment & Validation)
Builds
Custom automated electromechanical systems, fixtures, and production lines for surgical instruments
Domain
Medical device manufacturing / Minimally invasive surgery
Required skills
Mechanical design, electromechanical integration, robotics, validation (DQ/IQ/OQ/PQ), root cause analysis, continuous improvement, DFA/DFM, process analytics (FMEA, DoE, SPC, Cpk), engineering documentation
Preferred skills
MS in Engineering, ISO 13485/9001 experience, Solid modeling, prototyping, Robot programming (Fanuc, Denso), C/C++, Python, motion control algorithms
Technologies
Fanuc, Denso, C, C++, Python, Microsoft Office, data analytics tools
Responsibilities
Lead equipment transfer and duplication from global plants to Penang; oversee validation and qualification of manufacturing equipment; provide day-to-day line support and troubleshoot discrepant equipment; implement continuous improvement projects for yield and capacity; define KPIs and maintain compliance with medical device quality systems; create engineering documentation and specifications for custom tooling
Seniority
Senior, hands-on IC with team leadership