Senior Manufacturing Engineer
Core
Senior Manufacturing Engineer responsible for process owner, equipment commissioning, new product introduction, and quality improvement in a medical device manufacturing environment.
Role type
Senior Manufacturing Engineer (Process & Quality)
Builds
Commercial medical device products and manufacturing processes
Domain
Medical Devices / Manufacturing Engineering
Required skills
Manufacturing process design, Equipment commissioning, New Product Introduction (NPI), Quality systems (CAPA, MRB), Root cause analysis, Capacity planning, Project management, Lean/Six Sigma/Kaizen, Technical documentation, Cross-functional collaboration
Preferred skills
Calibration engineering, BSC systems, Equipment selection, Budget development, International travel
Technologies
BSC systems, Lean, Six Sigma, Kaizen, CAPA, MRB, NCEP
Responsibilities
Identify, order, and commission key process equipment to CGMP; Develop and modify manufacturing documentation and procedures; Ensure new products meet business, quality, output, and cost goals; Develop and modify manufacturing processes to improve quality and output; Perform product/process/vendor qualification activities; Support material discrepancy review and disposition activities; Eliminate/reduce product/process defects and improve yields; Train cross-functional team members; Maintain a valid capacity model; Provide equipment calibration services (if assigned to calibration role); Research and acquire new standards and capital equipment.
Seniority
Senior, hands-on IC