Assists in the development and analysis of products, materials, processes, or equipment. Under direct supervision/guidance, compiles, analyzes and reports operational, test, and research data to establish performance standards for newly designed or modified products, processes, or materials.
Undertakes and successfully completes simple or basic project/product development tasks to include any of the following: writing and/or verifying specifications, maintaining product/process documentation, testing processes, equipment, raw materials and product, and validating manufacturing equipment and processes.
May assist in inventing / creating concepts and designs/approaches for new products/processes/test methods.
Designs, procures, and fabricates simple tooling and fixtures.
Designs and coordinates rudimentary engineering tests and experiments.
Applies the Technical Development Process (TDP)/Product Development Process (PDP) methodologies, uses appropriate engineering tools (FMEA, process capability, etc.)
Prepares standard reports/documentation to communicate results to technical community.
Completes basic tasks on engineering documentation.
Train technicians/operators on new processes and/or test procedures.
Identifies areas for improvement, suggests solutions, and submits idea records.
Validate measurement techniques, test methods and manufacturing equipment including protocols and summary reports.
Ensure adequate engineering studies, design verifications and process validations are conducted such that well developed products are introduced into manufacturing.
Manages in order to ensure compliance with all relevant regulatory/legal requirements. This may consist of, but is not necessarily limited to, Unemployment Insurance, Americans with Disabilities (ADA), Affirmative Action, Family Medical Leave Act (FMLA), Equal Employment Opportunities Commission (EEOC), Environmental, Health and Safety including Occupational Safety and Health Administration (OSHA), Quality System Regulations (FDA), ISO 13485, MDD, PAL, CMDCAS, KFDA, other country specific Regulations as applicable.
May perform other duties as assigned by supervisor.
Build Quality into all aspects of their work by maintaining compliance to all quality requirements as well as support appropriate support in analysis and testing related to customer complaints or CAPA projects.
BS in Engineering/Technical Field.
0-2 years’ experience.