Sr Manufacturing Engineer at Master compliance

Job Title - Sr Manufacturing Engineer 
Job Location - North Haven, Connecticut. 
Job Description: -

• Support in-service operating systems to ensure continued operation and maintenance and optimization throughout. 

• Determine, select 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 revises 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 

• 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 

• Process Verification & Validation, IQ/OQ/PQ and TMV 

• DFMEA, PFMEA, Process Mapping and Critical to Quality reviews 

• DFA/DFM, Design and manufacturing documentation to include specifications, procedures, sampling methods, tolerance studies and GD&T 

• CAPA, Root Cause investigations quality tools to include DMAIC A3, 5 Whys, 6 M, Ishikawa Diagram and Pareto Charts 

• Dynamic, positive attitude and Strong communication, manufacturing process, product industrialization and leadership, presentation skills 

• Experience in assembly equipment technologies, well versed in molding, stamping and machining methods