Sr Manufacturing Engineer 

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