Senior Manufacturing Engineer
Core
Lead duplication, line transfer, and operational manufacturing line activities for complex mechanical assemblies in medical devices.
Role type
Senior Manufacturing Engineer (Mechanical)
Builds
Single Port robotic surgical platforms and complex electro-mechanical assemblies
Domain
Medical Devices / Robotic Surgery
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
3D modeling/CAD (SolidWorks), Lean principles, Root cause analysis (Fishbone, 8D), Statistical methods (Cpk, ANOVA, DOE), Component manufacturing processes (injection molding, transfer molding, thermoforming, machining, stamping, MIM), BOM specification, Work instruction creation
Preferred skills
Mid-volume manufacturing of single-use/resposable medical devices, ISO 13485 design controls, Machine tool experience
Technologies
SolidWorks
Responsibilities
Lead Design Verification and Validation (V&V) builds, Coordinate cut-in/implementation in production, Design and implement assembly/test fixtures, Create and revise manufacturing validation and risk documents (IQ/OQ/PQ/PPQ, Process FMEA)
Seniority
Senior, hands-on IC