Responsible for process development, tool design, machinery & equipment acquisition, manufacturing layout, continuous improvement, and engineering support of production for everyday manufacturing issues.Responsible for creating continuous improvement documents, such as FMEA, Root Cause Analysis, and process mapping.Execute value improvement projects that focused on reducing scrap rate and decrease component costs.Responsible for timely completion of CAPA investigations: initiation, evaluation (including risk assessment), investigation plans, investigations, implementation, effectiveness verification, risk re-evaluation, and final closure.Work on lean manufacturing initiatives including set-up reduction, workplace organization, standardized work, process / workflow improvements, visual management, and value stream mapping.Develop and validate manufacturing processes using tools such as Design of Experiments (DOE), Measurement System Analysis (MSA), and capability analysis.Identify and implementing effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.Responsible for product quality, including resolving quality problems, validating processes, developing and implementing process controls and inspection procedures using PFMEA and other risk management methodologies.Generate internal quality documentation such as quality plans, standard operating procedures, and inspection procedures.Utilize standard statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities.Responsible for reviewing design history files and manufacturing drawings (GD&T) to assist product development teams.Collaborate in validation process within cross functional departments such as technical operations, engineering, quality assurance, and regulatory affairs.Perform GAP Analysis and preparing remediation plans to address the gaps identified.Develop FAT, IQ, OQ and PQ protocols for product, processes, and equipment within the facility.Position requirements: Master's degree or a foreign equivalent degree in Mechanical Engineering, Engineering Management, Engineering (any) or related field.Position requires travel/relocation to various unanticipated client locations throughout the U.S with expenses paid by the employer.