A Day in the Life

Responsibilities may include the following and other duties may be assigned.

· 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.

Must Have: Minimum Requirement

· Bachelors degree required

· Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

Nice to Have

· Bachelor or Masters 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

· 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