Sr. Manufacturing Engineer (Thousand Oaks, CA)
Core
Lead cross-functional engineering projects to establish new product lines, retrofit equipment, and ensure medical device manufacturing compliance with regulatory standards.
Role type
Senior Manufacturing Engineer (Medical Devices)
Builds
New process/operation lines, manufacturing equipment, and standardized work instructions for medical implants and small Ti parts.
Domain
Medical Devices / Manufacturing Engineering
Required skills
Mechanical Engineering, Manufacturing Engineering, SolidWorks, CNC Machining, Injection Molding, Process Validation, Root Cause Analysis, FMEA, Lean Methodologies, SAP Configuration, Engineering Drawing Interpretation
Preferred skills
Medical Device experience, Swiss Machine experience, Titanium Machining, Six Sigma tools, AI implementation
Technologies
SolidWorks, SAP, CNC, Swiss Machines, PLC systems
Responsibilities
Lead cross-functional projects for new product lines and equipment retrofitting; Execute CAPA and root cause investigations; Collaborate with vendors on mold repair and design enhancements; Develop manual fixtures and assembly methods; Support SAP configuration and SOP development; Facilitate Kaizen events and continuous improvement; Assist in regulatory audits (ISO, BSI Micro); Evaluate production workflows and metrics; Create risk assessments (PFMEA); Generate engineering protocols and Change Orders.
Seniority
Senior, hands-on IC