Support and optimize the manufacturing and packaging of disposable diagnostic devices. Support projects which may include new products, new equipment, process improvements, and cost reductions.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Support production operations by trouble shooting and repairing automated assembly and packaging equipment in conjunction with the Maintenance team.
Investigate manufacturing yield or product nonconformance issues, determine root causes, and implement corrective and preventative actions.
Develop and revise manufacturing process documentation including material specifications, component and assembly drawings, and work instructions.
Support efforts to improve existing manufacturing processes and equipment to increase yield and reduce labor by specifying or designing the change, determining the return on investment, and implementing the change including commisioning and validation.
Support new product development from concept through launch by specifying, designing, and implementing manufacturing cells.
Participate in the development of Process FMEAs.
Implement lean manufacturing and process control techniques to support business goals.
Maintain compliance with all GMP and OraSure Quality System requirements.
Experience with specifying, purchasing, commissioning, and debugging assembly and packaging equipment.
Familiarity with equipment and system validation including IQ, OQ, and PQ protocols.
Ability to independently interpret machine manuals, mechanical design drawings (familiarity with electrical schematics and ladder logic/machine controls a plus).
Good analytical and problem solving skills. Previous experience with Statistical Process Control, Design of Experiments, and root cause analysis a plus.
Good communication skills, written and oral.
Experience with Solidworks and/or AutoCad a plus.
Able to work effectively in a cross-functional team.
Lean/Six Sigma experience a plus.
Experience in an ISO or GMP compliant organization preferred.
Must be capable of working in a diagnostic products manufacturing and/or an office environment at least 40 hours/week
Must be capable of operating a personal computer
Must be capable of giving and following written and oral directions
Must be capable of lifting up to 10 lbs
Must be capable of up to 10% travel
EDUCATION and/or EXPERIENCE
B.S. degree in Engineering (ChemE, ME or MfgE)
1-2 years Manufacturing Engineering experience in a medical or consumer products environment