We are seeking a Senior Manufacturing Engineer for a medical device company.
Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
Adapts machine or equipment design to factory and production conditions.
May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action for problems and deficiencies to ensure product quality.
Support in-service operating systems to ensure continued operation and maintenance and optimization throughout.
Determine, selec,t and implement technically feasible and economically viable alternatives for sustainment.
Analyze and evaluate how to improve a system and/or equipment's sustainability under continued operation, maintenance, and unexpected change.
Develop design changes to resolve operational issues, introduce new materials and revise product, process, and test specifications to enhance product quality, design integrity, reliability, and manufacturability.
Collect and evaluate service use and maintenance data; conduct root-cause analyses of in-service problems (e.g., operational hazards, deficiency reports, parts obsolescence, corrosion effects, reliability and maintainability trends, safety hazards, and failure causes and effects) and implement corrective action.
Nice to Have
Education: Bachelor or master's degree in engineering
FDA 21 CFR part 820, ISO 13485, ISO 14971 and GMP
Statistical analysis tools to include Minitab, DOE, process capability, measurement system and confidence interval analysis, Six Sigma