Katalyst CRO
Overview
Our Advanced Manufacturing Engineering group located in Danvers, Massachusetts is part of our Interventional Vascular & Structural Heart (IV&SH) group. We are currently seeking a Senior Manufacturing Engineer to lead and support projects within our Advanced Manufacturing Engineering group. Responsibilities
Develop and implement process and product improvements typically for projects of complex scope and wide magnitude. Equipment and fixturing: determine specific requirements of manufacturing operation to specify equipment, fixturing, and process parameters. Qualification and validation: develop plans to evaluate process repeatability and stability through equipment qualification and process validation. Continuous improvement and cost analysis: improve manufacturing methods, optimize product performance and reduce manufacturing costs in a systematic fashion; deploy Lean 6 Sigma methodology to identify opportunities for improvement and make recommendations. In partnership with Finance, perform detailed cost analyses of manufacturing changes and cost reduction projects. Production support and troubleshooting: provide engineering support to manufacturing operations and address issues on the production floor. Develop and optimize work design, manufacturing layout and product flow using Lean manufacturing principles. Qualifications
BS in Mechanical/Industrial Engineering or related field. 4+ years of regulated experience. Continuous improvement and cost analysis experience. IQ/OQ/PQ validations. Problem-solving, production and troubleshooting support. Experience developing and optimizing work design, manufacturing layouts and product flow. Medical device experience; cardiovascular experience is a plus. Seniority level
Associate Employment type
Contract Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr
Our Advanced Manufacturing Engineering group located in Danvers, Massachusetts is part of our Interventional Vascular & Structural Heart (IV&SH) group. We are currently seeking a Senior Manufacturing Engineer to lead and support projects within our Advanced Manufacturing Engineering group. Responsibilities
Develop and implement process and product improvements typically for projects of complex scope and wide magnitude. Equipment and fixturing: determine specific requirements of manufacturing operation to specify equipment, fixturing, and process parameters. Qualification and validation: develop plans to evaluate process repeatability and stability through equipment qualification and process validation. Continuous improvement and cost analysis: improve manufacturing methods, optimize product performance and reduce manufacturing costs in a systematic fashion; deploy Lean 6 Sigma methodology to identify opportunities for improvement and make recommendations. In partnership with Finance, perform detailed cost analyses of manufacturing changes and cost reduction projects. Production support and troubleshooting: provide engineering support to manufacturing operations and address issues on the production floor. Develop and optimize work design, manufacturing layout and product flow using Lean manufacturing principles. Qualifications
BS in Mechanical/Industrial Engineering or related field. 4+ years of regulated experience. Continuous improvement and cost analysis experience. IQ/OQ/PQ validations. Problem-solving, production and troubleshooting support. Experience developing and optimizing work design, manufacturing layouts and product flow. Medical device experience; cardiovascular experience is a plus. Seniority level
Associate Employment type
Contract Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr