JobMesh

Senior Engineer, Quality - Metals Process Engineering

Edwards Lifesciences · Draper, Utah, US

How You'll Make an Impact: - Investigate complex manufacturing product quality and compliance issues (e. g.

Job description

How You'll Make an Impact: Investigate complex manufacturing product quality and compliance issues (e.g., Material Review Board, CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports. Develop and implement optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk. Implement and monitor Critical Control Points. Develop, update, and maintain technical content of risk management files (e.g. FMEAs, Quality Control Plans). Develop, optimize and validate high complexity test methods and associated equipment. Collaborate with engineers for equipment selection and validation. Develop training and documentation materials for production and Receiving Inspection (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes. Implement and approve...